Job:CQV Package lead

Location:Bangalore

Experience:1015 Years

Job Description:

• 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 fastpaced 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 qualification.
• Should have hands on experience in validation deliverables like URS design review P&IDs FAT SAT IQ
• OQ PQs protocols and reports generation & execution etc.
• Should have good communication and collaboration skills enabling interaction with many stakeholders from different functions and cultures.
• Bachelor’s or master’s degree in a relevant science engineering or pharmaceutical field.
• 10 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.