Executive , Batch Compliance

Job Description

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