Assistant Manager - Production QMS (Formulations)

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, new 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