Executive - Production QMS

Role & responsibilities

• Knowledge and good experience on preparation of process documents i.e., (PCS, MFR, BMR/BPR, BOM), SOPs, qualification, study protocols, reports, checklists, justification report/note, campaign summary report, impact assessment report & other Bulk Manufacturing/Production associated shop-floor documents responsibilities related to microbial/mammalian biosimlars production.
• Good exposure on QMS documents and systems like initiation and closure of Change Control, Deviation, CAPA, EDMS, OOS, OOT and Trackwise related to production activities.
• Exposure on document preparation and investigation report, interim reports related to process
• Coordinate and follow-up with cross functional teams including QA team related to production QMS (Quality Management System) closures as per timelines based on site requirement.
• Follow and monitor the good documentation practices such as online documentation in BMR, equipment log books updation, record sheets etc. related to production activity and facility as per compliance requirements.
• Support and handling of SAP related activities, documents archival, follow-up LMS trainings related to production plan activities.
• Ensuring the implementation, maintenance and improvement of quality standards and processes within the production department.
• Knowledge on preparation of qualification protocol (URS/DQ/IQ/OQ/PQ), planning for commissioning/decommissioning and validation of the production related equipment or instruments.
• Support for internal and external audits, audit trials, inspections and regulatory assessment related to QMS - production activities.
• Participate and support for attending the trainings and QMS meetings as per site requirements for best practices in quality management to continuously improve the QMS for production.
• Tracking of newly joined personnel training records along with existing production team members.
• Participate in implementation of new production processes or equipment to ensure compliance with quality standards and regulatory requirements.
• Ensure and support If any additional job responsibilities shall assign by reporting manager.

Preferred candidate profile

Candidates from currently working in Biotech Firm will be preferred

Perks and benefits

As per Industry Norms