Assistant Manager – DP Medical Device
Location: India
Company: Biocon Biologics Limited
Department: DP Medical Device
Job ID: 19398
Employment Type: Full-Time
Estimated Salary: ₹8–12 LPA (based on experience and market standards)
Role Summary:
Biocon Biologics is seeking an Assistant Manager for the DP Medical Device division. The ideal candidate will lead documentation control, compliance tracking, and quality coordination for device production and inspection activities. This role demands a mature understanding of Good Documentation Practices (GDP), Change Control, CAPA, and deviation handling within a regulated manufacturing environment.
Key Responsibilities:
Documentation & Process Control:
Manage BMR requisition, receipt (including additional pages), and related execution checklists.
Oversee document numbering and effective dates for protocols, reports, and technical documents.
Supervise preparation, issuance, and archiving of logbooks.
Ensure accurate entry of logs for visual inspection and related documentation areas.
Review and organize completed logbooks for secure storage and future traceability.
Quality & Compliance Oversight:
Initiate, review, and verify execution of BMRs, change controls, CAPAs, and events.
Track lifecycle of quality actions (CFT reviews, approvals, closures).
Lead extension initiation and manage assigned CAPA/Event/Change Control for timely closure.
Investigate deviations and ensure closure in coordination with QA.
Hygiene, GDP, and SOP Adherence:
Monitor adherence to hygiene practices and report violations or incidents.
Uphold Good Documentation Practices across all documentation and log activities.
Conduct verification of documents and annexures for completeness and accuracy post-activity.
Candidate Profile:
Education: B.Sc. in Life Sciences, Biotechnology, or related field.
Experience: 10–13 years in pharmaceutical or medical device manufacturing/compliance/documentation.
Proven expertise in handling Change Control, CAPA, Deviations, and Quality Documentation.
Strong knowledge of GDP and regulatory expectations in a cGMP-compliant setting.
Ability to lead documentation teams, ensure process adherence, and coordinate with cross-functional departments.
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