Advanz Pharma is a global pharmaceutical company focused on providing patients with innovative and cost-effective healthcare solutions.
Not specified
INR 12.0 - 14.0 Lacs P.A.
Work from Office
Full Time
Specialist, Supply Chain Date: 20 Feb 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Location: Andheri, Mumbai. (Hybrid working) About ADVANZ PHARMA ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients. Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations. ADVANZ PHARMA s product portfolio and pipeline comprises innovative medicines, specialty generics biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases. We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity. About the Role As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for a Specialist Supply Planning. What youll do: Develop detailed understanding of manufacturing constraints and capabilities of the manufacturing locations being planned, providing regular feedback and information to drive medium term tactical and long-term strategic discussion. Communicate with Supplier/ CMOs and Sales Operations planning team of Supply Chain Keep all affected parties apprised of potential problems or issues impacting the business, including risks and opportunities. Oversee inventory and supply planning responsibilities for assigned plants and/or co-packers. For some locations/plants, responsibilities may also include inventory stock transfer/replenishment responsibilities. Utilize internal systems to proactively identify and communicate key drivers and proposed solutions to service and inventory issues Study, interpret and develop thorough understandings of problems and opportunities. Develop capacity-feasible supply plans and provide to the manufacturing sites on a prescribed schedule Develop detailed understanding of manufacturing constraints and capabilities of the manufacturing locations being planned, publishing and leading the review of material as needed with plant and business teams. Seamlessly interface with advanced levels of the organization to drive consensus on risks and opportunities and lead the conversations around developing action plans. Present findings that drive understanding, alignment and informed decision making. Coordinate/lead special projects as required. Projects include complex new product launch evaluation, asset utilization studies, supply chain cost optimization opportunities and others as assigned. Engineer tactical and strategic solutions that withstand the variability inherent to the business. Develop and execute inventory plans for a range of items. This includes short- and long-term plans for items produced internally and externally. Monitor and manage global inventories. This includes tracking inventory delivery performance and response time. Maintain and update planning systems, Anaplan, SAP with current and accurate data, including the addition of new orders, changes to delivery dates and quantities Must provide critical thinking, sound analysis, and appropriate decision making in support of both the supply planning and order management activities ( to other team) Procure for discrete group of SKUs with guidance from the Sales and Operations Planning Team. Advise management and appropriate internal teams of the current and future status of product supply for existing products for future launches To build effective, professional relationships with selected suppliers. To put in place and maintain a plan for each supplier encompassing day to day operational control, issues management, escalation routes and key milestones To keep appropriately detailed records of all matters pertaining to each supplier. To maintain a supply risk profile by supplier to include a continuous improvement program to mitigate the identified risks. To produce reports to an agreed timetable. To develop and propose a medium and long-term supplier strategy. Contribute to making ADVANZ PHARMA a desired place to work. About You We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients lives. For this role, you will also have the following: Qualifications: Graduate with Pharma/science background in relevant subject or equivalent in experience. Master s degree in supply chain management is preferred. Knowledge, Skills Experience: Must have significant experience in Supply chain management inventory planning of a pharmaceutical/ manufacturing company. Relevant experience in planning managing contract manufacturers. Advanced skills including all Microsoft Products (EXCEL and Power Point especially) SAP - MM module. Ability to communicate effectively with internal and external customers. Solution finding mindset and capability. Proactive nature with focus on proactive prevention of possible issues. Ability to work with different Global culture and different time zones. Have a bias for action and fast decision making. A positive and can-do approach , biased towards finding solutions and embracing change. Thrive in an entrepreneurial environment and take accountability for results. Embrace challenge and change, applying a growth mindset approach. Consistent demonstration and embodiment of company core values: Entrepreneurship, Speed, and Integrity. Learning agility and scalability , with a desire to continuously improve and develop as ADVANZ grows. Work collaboratively across all business functions with an open, honest, and respectful cooperation. Why ADVANZ PHARMA The success of any company is driven by its people, and we are no different. At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact. Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients lives by providing and enhancing the specialty and hospital medicines they depend on. As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you ll be empowered to own your work, explore new possibilities, and make things happen. But there s more to you and us than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles we have an active ADVANZ PHARMA Women s Network; almost 40% of our managers are women. We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication. We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.
Not specified
INR 7.0 - 8.0 Lacs P.A.
Work from Office
Full Time
Executive, Batch Compliance Date: 10 Feb 2025 Location: Andheri (East), IN, Mumbai 400 Company: AdvanzPharma Job Title: Executive - Batch Compliance Department: Quality Location: Mumbai Grade - P1 Reports to: Manager - Quality Main purpose of role: To ensure batches are released in accordance with defined procedures and within appropriate timeframes to support business need. Key responsibilities (In Points): To perform accurate and timely review of various batch documents and confirm that the batch meets the relevant regulatory standards before being placed on the market To coordinate with the contract testing laboratory/ Manufacturers for timely analysis and provide support during technical troubleshooting. To liaise with the Global Supply Chain Management team in support of the assessment of batch/manufacturer information and business priorities To ensure that the relevant database is update with every batch released To report any out of specification or out of trend result and assist the deviation team during investigation. To support the business during tender applications by providing various quality related documents and accessories. To improve the overall cycle time on batch release. To assess the performance of every manufacturer and prepare a risk assessment report determining the level of detailed information required during batch release To ensure that the batch release and other associated SOPs are thoroughly followed and suggest improvement. Preparation of individual and team monthly reports. To ensure products are blocked/ unblocked as per request from GxP teams and relevant database is update with every action. To monitor low stock/ out of stock products and facilitate in quick release of these products. Other activities as may be required, at the discretion of management Requirement Essential Desirable Qualifications: Science Graduate (Chemistry/Biology/Pharmacy (or close equivalent) X Post graduate qualification in a relevant scientific discipline X Experience Competences: Hands on experience of at least 3 to 5 years on various laboratory instruments like HPLC, GC in a reputed Pharmaceutical company X Has experience of working in a virtual company environment X Candidate should have a thorough knowledge of cGMP and GLP and should have a good analysing and communication skills X Candidates having experience in MHRA or USFDA approved companies will have added preference X Knowledge Skills: Competent use of grammatically correct written and spoken English X Knowledge of MS Office (Word, Excel, Outlook, PowerPoint), Adobe Acrobat and web applications. X Knowledge of SAP, Veeva or equivalent software X Knowledge of European Regulations, Guidelines for pharmaceutical products X Knowledge of technical aspects of product manufacture including quality control and compliance X Personal Qualities: A Methodical, Hardworking individual X Specific awareness of Company s culture and objectives X Organization and time management skills X Ability to adapt to change X Proactive
Not specified
INR 5.0 - 9.0 Lacs P.A.
Work from Office
Full Time
Department: Quality Location: Mumbai Reports to: Manager - Supplier Assurance (London) Main purpose of role: The Supplier Assurance Team is responsible for the Quality related aspects of Supplier Management, ensuring Quality Technical Agreements are in place and maintained. Ensuring Self inspection program is in place and executed, with necessary corrective and preventive actions implemented. This role provides a good opportunity to gain exposure and knowledge of a range of functions and activities in the Pharmaceutical industry. The role requires cross-functional/departmental interaction working closely with Supply Chain, Supplier Alliance, Regulatory, Operational Projects, New Product Introduction and Quality. Key responsibilities (In Points): Coordinate GMP/GDP Quality Technical agreements for approximately 400 third party manufacturers, distributors, laboratories and other GxP vendors. Ensure all elements of GMP / GDP/ MDR responsibility are correctly assigned through consultation with Supply Chain, Legal and Quality teams and ensure that scheduled review periods are assigned and met. Liaise with the third-party GxP vendors to gain agreement and approval for the Quality Technical agreements and assist in resolving any queries. Ensure risks associated with supplier issues are risk assessed and are appropriately classified and communicated/escalated where the continued use of the suppliers is justified. Review and maintain the vendor master list, ensuring supplier details are up to date and in the correct status with appropriate qualification activities assigned. Liaise with other vendor master list end users to periodic review and maintain the vendor master list. Prepare, communicate, maintain, manage and report GMP/GDP self-inspection annual audit program. Co-ordinate with internal lead auditors to ensure Internal auditor qualification summaries are in place, timely conduction of the audit plan, write up of reports, response from auditee received and initiation of CAPA plan. Maintain supplier notification log and ensure supplier notifications are forward to relevant department for actioning. Maintain SOP and WIs for Technical Agreements, Self-Inspection and supplier notifications. Assist with corrective and preventative action plans (both internally and with external suppliers). Other activities as may be required, at the discretion of management Requirement Qualifications: Graduate in Science related subject or equivalent Experience Competences: Fluent in written and spoken English Experience of working within a Pharmaceutical company Experienced in the outsourcing of GxP activities in a virtual environment Experience of coordinating or administering processes with external parties. Experience of conducting or coordinating audits or inspections Capable of working to deadlines Proven ability to organize and prioritize multiple task Ability to work on own initiative and juggle priorities Advance understanding of the GxPs / regulations associated with the role Ability to lead improvement projects in the area Ability to communicate/escalate identified issues to mitigate risk and minimize business impact Ability to effectively conduct investigations in subject and associated areas, identify root cause and appropriate CAPA Ability to work effectively as part of a team Knowledge Skills: Knowledge of GMP and GDP requirements Knowledge of one of the following areas requirements; MDR, sterile manufacturing, biologics, local GxP requirements of specific countries or clinical GxP would be an advantage Strong attention to detail Ability to communicate effectively with internal and external customers Proactive nature with focus on prevention of possible issues. Sound problem-solving skills Excellent organization and time management skills Personal Qualities: Agile, prolific communication skills, proactive, stakeholder centric focus at all times, team player and willing to take accountability
Not specified
INR 5.0 - 6.0 Lacs P.A.
Work from Office
Full Time
Department: Quality Reports to: Manager Compliance (Quality) Main purpose of role: The Quality Compliance Team within the Quality Department is responsible for ensuring Contract Manufacturing Organizations (CMOs) are provided with current Marketing Authorization information and ensuring that CMOs comply with this information and Pharmacopoeial requirements. This role ensures compliance with registered information and Pharmacopoeial requirements by: Ensuring license non-compliances as identified through already established Compliance processes are addressed within a pre-defined timeframe based on risk. Performing Compliance review of new and revised critical Module 3 documents as compiled by Regulatory, prior to submission. The Senior Executive- Quality Compliance has a cross-functional role working closely with Regulatory Affairs, Technical, Operations projects, other Quality functions and CMOs to ensure the above is achieved. Key responsibilities (In Points): Owning Compliance related change controls pertaining license updates and ensuring such changes are progressed and closed within timelines. Establishing business and Quality needs and criticality for identified license non-compliances and closing license gaps as dictated by this information. Writing supporting Quality related submission documents, as necessary. Managing workload appropriately with the ability to re-prioritize rapidly as necessary. Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritized. Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant. Managing associated submission RFls within timeframe. Quality Compliance owner for Technical Transfers projects, involving performance of gap assessment between prospective CMO and current registered information and working toward established project timelines. Liaising with external stakeholders including Contract Manufacturing Organizations and building key relationships. Quality Compliance SME for Projects owned by both the Compliance team and other departments. Requirement Essential Desirable Qualifications: Minimum Degree in Chemistry, Pharmacy or Microbiology Post Graduate Qualification in relevant scientific discipline Experience Competences: Minimum 5 years experience of working in a similar role within a pharmaceutical industry Extensive GxP knowledge across all dosage forms Experience in authoring Module 3 in CTD format Experience in interpreting manufacturing and testing information (Critical Vs. Non-critical) for submission purpose Experience in ensuring that accurate, adequate and appropriate data is incorporated in Module 3 so as to ensure right first submissions Experience in writing supporting submission documents (e.g. justifications to support post marketing changes and response (to RFI) Extensive knowledge of QMS, specifically change controls and risk assessments, and continuous improvements Capable of working to deadlines remain calm under pressure Proven ability to organize and prioritize multiple tasks Ability to work effectively as part of a team and cross functionally Knowledge Skills: Knowledge of regulatory guidance for variations Excellent communication skills, both oral and written, to include senior management in third party suppliers Sound working knowledge of all Microsoft Office applications Well organized with logical methodical approach to work Sound problem-solving skills Good organization time management skills Personal Qualities: Professional, methodical approach to work with can-do attitude Even tempered, positive persona, approachable Helpful flexible with strong team spirit Cultural leader for core values
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