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

Role: Production & Manufacturing - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Production, Manufacturing & Engineering, Employment Type: Full Time, Permanent Role Category: Production & Manufacturing - Other Education UG: B.Pharma in Any Specialization PG: M.Pharma in Any Specialization read more

Key Skills Skills highlighted with ‘‘ are preferred keyskills Equipment QualificationProduction ManagementIQ PQOQ

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