Assistant Manager - IPQA(DS)

Enzene Biosciences Ltd; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

A leading biotech firm in Pune is seeking a professional to manage documentation for various change controls and validations, including Process and Cleaning Validation. Responsibilities include review of QA protocols and Internal Audit programs. Candidates should have experience in managing technical documents and quality assurance practices. This role is crucial for maintaining compliance and ensuring efficient operations within the organization.

Responsibilities

• Handle documentation for Change Control, Deviation, OOS, CAPA.
• Manage Cell Bank and Technology Transfer Documents.
• Review Process validation protocols and reports.
• Conduct IPQA shop floor investigations.
• Monitor Internal Audit programs for Good Manufacturing practices.
• Handling of JMP software for CPV and PQR.
• Execute and monitor the Internal Audit programs to maintain the Good Manufacturing practices within the organization.
• Management of QA team it engagements.

Job description

Responsibilities

• Documentation handling and preparation of Change Control, Deviation, OOS, CAPA, Lab incident, APQR and investigation, follow up for the closure of the same.
• Handling of Cell Bank Documents and Technology Transfer Documents.
• Review of Process validation protocol and report, Review of Cleaning Validation protocol and report, Batch records.
• Review of CPV data.
• IPQA shop floors investigation.
• Handling of JMP software for CPV and PQR.
• Execute and monitor the Internal Audit programs to maintain the Good Manufacturing practices within the organization.
• Management of QA team it engagements.