Location Bangalore India Seniority 15 yrs Department Commissioning and Qualification USP DSP Clean utilities How you might spend your days Main Roles Responsibilities As Manager - C Q you ll be working with highly skilled Senior Engineers and Engineers and still growing across Denmark and Indian team s where you ll 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 solid 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 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 Who you are Preferred Competencies We care about who you are as a person In the end how you work and your energy is what impacts the effort we do as a team As a Biotech person you Project management skills regarding C Q facilitating board meetings to review status timelines quality challenges generating reports for steering group understanding to evaluate risk and its mitigation strategies Thrives in a fast-paced environment with many concurrent tasks Need to train the team in performing the site activities and handling different stakeholders Support onsite and offsite activities such as FATs SATs IOQ and PQ Executions and System Walkdowns Hands on experience in planning directing C Q activities of process equipment s upstream and downstream and clean utilities in DS facility qualification Should have experience in validation deliverables like URS design review P IDs FAT SAT IQ OQ PQs Test protocols and reports generation execution etc Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures The miles you ve walked Education and Work Experience In all positions there are some things that are needed and others a bonus We believe these qualifications are needed for you to do well in this role 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

📌 Manager Cqv (Bengaluru)
🏢 People First Consultants
📍 Bengaluru