Commissioning & Qualification –Manager
India, Bangalore
Fulltime: 50 hrs a week
Experience: > 10 Years
Life Sciences
Introduction
We are recruiting a Commissioning & Qualification - Manager to join one of our leading multinational clients and their expanding team. This position is Bangalore based in and offers an excellent opportunity for experienced proposal management professionals in the Life Science sector.
What are you going to do
Position: Commissioning & Qualification - Manager.
Contract: On Permanent Role.
- Would be part of the Project team involved in making complex biopharma/Large API facilities
- Driving the project with Science and Risk based Validation (SRV) concept.
- Work very closely with our customers, Extensive Travelling Involved.
- Have strong leadership qualities to lead a team of C&Q Engineers/Leads and aligning with Multiple stakeholders.
- Have knowledge of process equipment’s systems
- To drive C&Q activities with multiple stakeholders like (Engineering responsible, Design consultant, Vendor’s, and QA) of the project organization:
- Align quality and validation concept with customer’s quality system & validation concept.
- Define scope of C&Q activities in the project and scope of work within quality work package incl. relevant C&Q activities.
- Ensure changes to scope are brought to the attention of Project Management.
- Ensure interfaces to and coordination with other disciplines
- Review work of project members in the quality work package.
- Generate validation deliverables like IQ, OQ, PQ protocols and reports, etc.
- Act as Smarter Execution consultant for Project Members.
- Ensure C&Q documentation is in compliance with GMP and GEP (incl. ASTM E2500).
- Conduct follow-up on QAP, Project execution Plan on C&Q activities
- Having work experience on QMS based Project environment
Essential skills and knowledge
- Bachelor’s or master’s degree in a relevant science, engineering, or pharmaceutical field.
- 15+ years’ experience performing commissioning and / or qualification activities in an FDA regulated industry.
- Ideally you will already have experience in equipment qualification.
- Should have knowledge with recent edition of ISPE C&Q and GAMP and regulatory guidelines USFDA, EU GMP, Annexure 11 & 21 CFR 11 and ICH guidelines.
What we offer
Why work with Brunel? We take pride in offering exciting career opportunities through our network of 120+ offices across 40+ countries. We understand that advancing your career requires dedication and the right support—let us match you with your ideal position in the energy sector.