Assistant Manager - Production QMS (Formulations)

Rubicon Research; Mumbai, Ambernath; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Rubicon Research in Mumbai is seeking a qualified professional to own the end-to-end qualification lifecycle for manufacturing equipment, facilities, utilities and ancillary systems, ensuring they are qualified and fit for intended use.

You will plan, coordinate, execute and close IQ, OQ and PQ protocols, review strategies and reports, maintain cGMP compliance, assess impact of changes, lead requalification, and support technology transfer and scale-up with cross-functional teams to sustain

Qualifications

• Qualification lifecycle ownership for equipment, facilities, utilities and ancillary systems.
• Plan and coordinate qualification activities for new equipment and process changes.
• Review and execute IQ, OQ and PQ protocols and reports with traceability.
• Ensure compliance with cGMP and regulatory requirements throughout qualification lifecycle.

Responsibilities

• 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 and process changes, 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.

Skills

Cross-functional coordination

Qualification planning

Project coordination

IQ/OQ/PQ execution

Education

B. Pharm /M. Pharm

Tools

QMS documents handling

Job description

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