Executive

Job Purpose

To execute and support day-to-day manufacturing operations for biosimilar products in accordance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and applicable regulatory requirements. The role is responsible for carrying out assigned manufacturing activities, maintaining accurate documentation, ensuring equipment readiness, adhering to safety and hygiene requirements, and supporting the timely execution of production plans.

The position requires close coordination with Production, Quality Assurance (QA), Quality Control (QC), Engineering, Warehouse, Microbiology, and other relevant functions to ensure consistent product quality, process compliance, operational efficiency, and safe manufacturing practices. The Executive is expected to contribute to process improvement, deviation prevention, and the development of a strong quality culture within the Biosimilars Manufacturing facility.

3. Key Responsibilities
A. Biosimilar Manufacturing Operations

- Execute assigned manufacturing activities for biosimilar products as per approved procedures, manufacturing instructions, and production schedules.
- Support upstream and downstream manufacturing operations, as applicable to the assigned process and level of qualification.
- Perform activities such as media and buffer preparation, equipment setup, material preparation, solution preparation, and process execution as authorized.
- Support cell culture, seed preparation, bioreactor operations, harvest, clarification, purification, filtration, and other bioprocessing activities where applicable.
- Follow approved process parameters, operating ranges, hold times, and in-process control requirements.
- Ensure that manufacturing activities are performed only after required area, equipment, material, and documentation checks have been completed.
- Monitor process parameters and promptly report any abnormal observations, alarms, deviations, or unexpected process conditions to the supervisor.
- Ensure adherence to production schedules while maintaining product quality and process integrity.
- Coordinate with team members and supervisors to resolve routine operational issues within the scope of assigned responsibilities.
- Ensure that all manufacturing operations are performed by trained and authorized personnel.
B. Batch Documentation and Good Documentation Practices

- Complete Batch Manufacturing Records, equipment usage logs, cleaning records, process checklists, and other controlled documents contemporaneously and accurately.
- Ensure that all entries are legible, traceable, complete, and compliant with Good Documentation Practices.
- Record actual process parameters, material quantities, equipment identification, start and end times, and other required manufacturing information.
- Verify the availability and correctness of approved manufacturing documents before commencing assigned activities.
- Ensure that corrections, where necessary, are made in accordance with approved documentation procedures.
- Report documentation errors, omissions, discrepancies, or data-integrity concerns to the supervisor immediately.
- Maintain records of equipment cleaning, area cleaning, line clearance, and other manufacturing activities as applicable.
- Support batch record review by ensuring that assigned documentation is complete and readily available for verification.
- Maintain confidentiality, traceability, and security of manufacturing records in accordance with company policies.
C. Compliance with GMP and Quality Systems

- Follow applicable GMP requirements, approved SOPs, work instructions, and site quality policies.
- Ensure compliance with approved gowning procedures, personnel entry and exit requirements, and hygiene practices.
- Follow aseptic practices and contamination-control requirements in designated cleanroom areas, where applicable.
- Adhere to area classification requirements, environmental controls, and material and personnel movement procedures.
- Ensure that materials and equipment are used only after the required status checks and approvals.
- Support implementation of contamination prevention measures and cross-contamination control practices.
- Report deviations, non-conformances, equipment failures, and potential quality risks promptly.
- Participate