8 - 13 years

6.0 - 9.0 Lacs P.A.

Jadcherla

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Validation and QualificationEquipment OperationLean Manufacturing PrinciplesFDA RegulationsPackaging Materials & TechnologiesPackaging SchedulesSerialization and Track & Trace RequirementsQuality AuditsPackaging OperationsLeadership & Team Management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description Overview: We are looking for a meticulous and experienced Packing Assistant Manager to spearhead our pharmaceutical packaging operations at Evertogen Life Sciences. This pivotal role demands a professional adept at overseeing daily packaging processes, ensuring strict adherence to GMP and regulatory standards, and driving continuous improvement initiatives. The ideal candidate will possess a strong understanding of pharmaceutical packaging regulations, coupled with proven leadership skills to effectively manage and train packaging staff. You will be responsible for developing and implementing packaging schedules, monitoring performance metrics, and collaborating with cross-functional teams to resolve any packaging-related challenges. Your expertise in quality audits, process validation, and statistical process control will be crucial in maintaining the highest standards of product integrity and operational efficiency. Furthermore, you will leverage your knowledge of lean manufacturing principles and serialization/track & trace requirements to optimize production workflow and ensure compliance with global regulatory bodies like the FDA and EMA. If you are a proactive leader with a passion for excellence in pharmaceutical packaging, we encourage you to apply and contribute to our mission of delivering high-quality medications to the world. Job Details: Industry: Pharmaceutical Department: Packaging Operations Role: Packing Assistant Manager Location: Jadcherla Compensation: 9,00,000/Annum Experience: 8+ Years Employment Type: Full-time Qualification: Bachelor's degree in Pharmacy, Engineering, or a related field Responsibilities: Packaging Operations Management Oversee and manage daily pharmaceutical packaging operations to ensure timely and efficient production, meeting established targets and deadlines. Develop and implement detailed packaging schedules in close coordination with production, warehouse, and logistics departments to optimize material flow. Monitor packaging processes and key performance indicators (KPIs) to proactively identify areas for improvement and implement corrective actions. Ensure strict adherence to Good Manufacturing Practices (GMP), FDA regulations (21 CFR Part 211), and EMA regulations throughout the packaging process. Lead the implementation of serialization and track & trace requirements, ensuring full compliance with global standards and regulations. Implement and maintain robust batch records management practices, ensuring accurate documentation and traceability of all packaging activities. Quality Assurance and Compliance Conduct regular quality audits of packaged products and packaging processes to maintain the highest standards of product integrity and compliance. Collaborate with the Quality Assurance department to resolve any quality-related issues and implement preventative action measures to avoid recurrence. Ensure all packaging materials and processes are validated and qualified according to established protocols and regulatory requirements. Implement and maintain statistical process control (SPC) techniques to monitor and control critical packaging parameters, ensuring consistent quality. Oversee the change management process for packaging-related changes, ensuring thorough risk assessments and appropriate documentation. Manage and maintain accurate documentation related to packaging operations, including standard operating procedures (SOPs) and training records. Team Leadership and Training Train, supervise, and mentor packaging staff, ensuring they are equipped with the necessary skills and knowledge to perform their duties effectively. Foster a culture of continuous improvement and teamwork within the packaging department, encouraging active participation in problem-solving and process optimization. Conduct performance evaluations and provide feedback to packaging staff, identifying areas for development and growth. Lead and facilitate team meetings to communicate updates, address concerns, and promote collaboration across different functional areas. Ensure adherence to safety protocols and procedures, promoting a safe and healthy working environment for all packaging staff. Develop and implement training programs on GMP, packaging equipment operation, and other relevant topics to enhance staff competency. Process Improvement and Optimization Identify and implement process improvements to optimize packaging workflow, reduce waste, and improve overall efficiency using Lean Manufacturing Principles and Six Sigma methodologies. Analyze packaging processes using root cause analysis techniques to identify and address underlying issues affecting performance and quality. Collaborate with Engineering and Maintenance departments to ensure packaging equipment is properly maintained and calibrated, minimizing downtime. Implement and maintain the 5S methodology to create a clean, organized, and efficient work environment within the packaging area. Monitor and improve Overall Equipment Effectiveness (OEE) for packaging equipment, identifying and addressing factors that impact equipment performance. Lead projects to implement new packaging technologies and equipment, ensuring successful integration and validation. Cross-Functional Collaboration and Stakeholder Management Collaborate with other departments, such as Production, Quality Assurance, Engineering, and Supply Chain, to resolve any issues that arise during the packaging process. Participate in cross-functional teams to develop and implement solutions to improve overall operational efficiency and product quality. Liaise with vendor management (packaging suppliers) to ensure timely delivery of quality packaging materials and resolve any supply chain-related issues. Work with artwork management to ensure accurate and compliant packaging labels and artwork. Communicate effectively with stakeholders at all levels of the organization, providing updates on packaging operations and addressing any concerns. Participate in internal and external audits, providing support and documentation as needed. General Expectations and Past Experiences: Possess a Bachelor's degree in Pharmacy, Engineering, or a related field with 8+ years of experience in pharmaceutical packaging operations, demonstrating progressive leadership. Demonstrated expertise in GMP compliance and pharmaceutical packaging regulations (21 CFR Part 211), with a strong understanding of FDA and EMA guidelines. Proven ability to lead and manage packaging teams, with experience in training, performance management, and conflict resolution. Proficient in statistical process control (SPC) and other quality management tools, with a track record of implementing process improvements to enhance efficiency and reduce waste. Experience in validation and qualification of packaging equipment and processes, ensuring compliance with regulatory requirements. Strong analytical and problem-solving skills, with the ability to identify and address issues affecting packaging performance and quality using root cause analysis. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

Biopharmaceuticals
Hyderabad

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