Role & responsibilities

Purpose:

To ensure that all manufacturing equipment, facilities and systems are qualified, compliant and available for intended production use by effectively planning, executing and closing qualification activities, managing requalification and qualification-related changes, and providing technical qualification support to manufacturing projects and technology transfers without impacting production continuity.

- Own the end-to-end qualification lifecycle for manufacturing equipment, facilities, utilities and ancillary systems, ensuring they are qualified and fit for intended use.
- Plan and coordinate qualification activities for new equipment, facility modifications, process changes and manufacturing projects, ensuring timely completion without impacting production.
- Review, approve and execute qualification strategies, protocols and reports including IQ, OQ and PQ, ensuring scientific rationale, appropriate acceptance criteria and complete traceability.
- Ensure compliance with cGMP and regulatory requirements throughout qualification execution, documentation and lifecycle management.
- Assess qualification impact of change controls and define requirements for qualification, requalification or additional studies arising from equipment, process, facility and utility changes.
- Own the periodic requalification program, ensuring schedules are proactively planned, monitored and completed within defined timelines.




- Lead qualification deviation management, ensuring effective investigation, root-cause identification, CAPA implementation and timely closure.
- Conduct and review qualification risk assessments to establish appropriate qualification scope, testing requirements and acceptance criteria.
- Provide qualification expertise for technology transfer, recent product introduction, scale-up and manufacturing projects, ensuring qualification requirements are incorporated and delivered as per project timelines.
- Drive qualification excellence and inspection readiness through robust documentation, effective cross-functional coordination, performance monitoring and continuous improvement of qualification practices. Maintain qualification schedule and monitor periodic review and requalification schedules.

Preferred candidate profile

- B. Pharm /M. Pharm
- Basic knowledge of unit operations involved in manufacturing of solid oral dosage forms i.e. Granulation, Blending, Compression, Coating, Capsulation etc.
- Working Knowledge of QMS documents handling like Change control, Deviation, Qualification, Risk Assessment
- Good capability of cross functional coordination with Manufacturing, Engineering, QA, Project and Validation teams
- Ability to plan and execute multiple qualification activities in timelines and minimizing impact on production operations

📌 Assistant Manager - Production QMS (Formulations) (Mumbai)
🏢 Rubicon Research
📍 Mumbai