Job Description

JOB Responsibilities

• Responsible for compliance with cGMP and related elements like facilities, documentation, trainings, reports, records during manufacturing operations. Preparation and Review of GMP documents related to Mammalian and Drug Product Manufacturing Department.
• To prepare and review documents like Risk Assessment protocols for product change over, Cleaning/Process Validation protocols, Master Formula Records, Batch Manufacturing Records. Review technology transfer documents for Mammalian and Microbial products with coordination with R&D, QC and RA.
• To raise and handle the documents like Change controls, deviations, CAPA, Investigation reports for Mammalian Manufacturing.
• To prepare and review IQ, OQ, PQ and RQ documents for equipment qualification in Mammalian Manufacturing Department.
• To participate in equipment and facility qualification, requalification, process and cleaning validation.
• To ensure GMP compliances during plant operations & during audit by regulatory agency. Facility preparedness for GMP audits. To conduct quality based audits, investigations and root cause analysis to promote continuous improvement.
• Involved in dossier and other regulatory document writing.
• Personnel safety compliance in co-ordination with EHS team.
• In-plant training to colleagues and contractual staff. Coordinator for departmental trainings.
• Assure the interface of manufacturing department with other departments like QA, QC, warehouse, R&D and engineering.
• Participate in investigations related to process, documents and incidents as and when required.
• Document Control: Log Book Issuance and Archival.
• To do the management of electronic document to GMP standards.
• To perform the Computer software validation of computerized systems (Existing and new).

1. Additional Job Responsibilities:

• Investigations of incidents related to safety. Coordinator for EHS.
• Any responsibility advised by the superior from time to time.
• Coordination with Engineering, QA, QC, R&D, Purchase, and warehouse departments.
• To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site.

The above list is not exhaustive and may be assigned additional responsibilities from time to time.

In the absence, the above Job Responsibilities shall be done by competent / trained personnel from team.

Work Experience

3-5 years of experience

Education

Masters in Biotechnology

Competencies