Team Member - Production

Roles & Responsibilities - PFS Line

• Adhere to the safety norms, company policies and procedures.
• To ensure the availability of machine and material to achieve the production plan in his area of work.
• Maintaining cGMP practices in production area including line clearance before related activities.
• Responsible for operation of vial washing, tunnel sterilizer, filling, stoppering machine of Tofflon line (Bausch & strobel).
• Responsible for activities related to filling like Operation and cleaning of  machines like,  Dry powder line and related online documentation in BMR, log-books, PAS|X and SAP as per Good Documentation Practice.
• To coordinate for planning of preventive maintenance of major equipment and calibration of measuring devices in production.
• Responsible for on time closure of breakdowns and coordination with relevant departments for the same activities.
• To follow and monitor the aseptic practices in Isolators.
• To ensure the cleaning and sanitization of filling area.
• To coordinate for the quality notification i.e. CRN, incident, CAPA as per requirement.
• To ensure that yield of the product at respective stage of batch processing is within the Specified limits.
• To coordinate for timely completion of calibration, preventive maintenance, Qualification / validation of equipment as per schedule.
• To prepare and review GMP documents like SOP, BMR, URS, Investigation report, OOS and risk assessment Report etc.
• Participation in media fill as per the schedule.
• Daily reporting to the Team Leader.
• On time completion of training in LMS.
• To perform any other tasks / projects assigned by Team Leader.
• To review interventions, audit trails, alarms history in routine product batches
• To participate in inspections (Internal/External), audit response preparation and 
• Correction of identified discrepancies.

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Function: Other
Experience Level: Mid-Senior Level