CQV/QAV Consultant

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: CQV/QAV Consultant
Location: Wayne, PA
Duration: Long Term

Job Overview
We are seeking an experienced CQV/QAV Consultant with 9+ years of experience, including strong hands-on experience with aseptic fill/finish lines in pharmaceutical or biopharmaceutical manufacturing environments.

Key Responsibilities

• Support commissioning, qualification, and validation activities for aseptic fill/finish systems.
• Execute and review IQ/OQ/PQ protocols and reports.
• Support qualification of filling lines and sterile manufacturing equipment.
• Work with aseptic filling, isolators/RABS, lyophilizers, autoclaves, and related equipment.
• Support equipment startup, troubleshooting, and validation activities.
• Prepare and review validation documentation.
• Support deviations, change controls, CAPA, and investigation activities.
• Work with Engineering, Quality, Manufacturing, and Validation teams.
• Ensure activities comply with GMP/cGMP requirements.

Required Qualifications

• 9+ years of relevant CQV/QAV/Validation experience.
• Strong hands-on experience with aseptic fill/finish lines.
• Experience in pharmaceutical or biopharmaceutical manufacturing.
• Strong experience with IQ/OQ/PQ.
• Experience with sterile filling and manufacturing equipment.
• Knowledge of GMP/cGMP requirements.
• Experience with commissioning, qualification, and validation.
• Strong documentation and troubleshooting skills.
• Good communication and teamwork skills.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.