CQV Technical Lead - Fill Finish

1w1 week ago

Callista

CH · Full-time · CHF 130,000 – CHF 170,000

About this role

We are seeking a highly skilled CQV Technical Lead with extensive Fill Finish experience. The successful candidate will lead CQV activities for Fill Finish processes. Ensuring compliance with regulatory standards and company procedures is essential.

Lead and execute CQV activities for Fill Finish equipment and processes daily. Develop and review validation protocols including IQ, OQ, PQ and reports. Troubleshoot and resolve technical issues related to Fill Finish processes.

Coordinate with cross-functional teams to ensure timely completion of CQV deliverables. Provide technical expertise and guidance to project teams and stakeholders. Ensure adherence to GMP, FDA, and other regulatory requirements.

Maintain accurate documentation and records of CQV activities. Gain exposure to aseptic processing and sterile manufacturing environments. Opportunity to apply project management skills in a specialized pharmaceutical setting.

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field
Minimum of 5 years of experience in CQV with a focus on Fill Finish processes
Strong knowledge of GMP, FDA, and other regulatory requirements
Excellent problem-solving and analytical skills
Effective communication and team collaboration abilities
Ability to work independently and manage multiple tasks effectively
Experience with aseptic processing and sterile manufacturing
Familiarity with automated systems and equipment used in Fill Finish processes

Responsibilities

Lead and execute CQV activities for Fill Finish equipment and processes
Develop and review validation protocols (IQ, OQ, PQ) and reports
Coordinate with cross-functional teams to ensure timely completion of CQV deliverables
Troubleshoot and resolve technical issues related to Fill Finish processes
Ensure adherence to GMP, FDA, and other regulatory requirements
Provide technical expertise and guidance to project teams and stakeholders
Maintain accurate documentation and records of CQV activities