Job Function
In association with the SDP Area CQV Lead prepare and execute the site commissioning and validation testing for equipment utilities at the clients Drug Product Facility in alignment with site and global client procedures.
Responsibilities
* Development and execution of CQV testing documentation forfilling line systems including Syringe and Vial line/ isolators, Lyos and associated equipment for the Sterile Drug product facility. 100%
* Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.
* Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
* Responsible for ensuring that all Inspection equipment, is tested in compliance with project related standards from a commissioning perspective.
* Deviation management associated with the assigned equipment and utilities.
* Risk Management - Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
* Execution of FAT testing and leveraging results into overall qualification process for assigned equipment, facilities and utilities.
* Ensuring all assigned training is executed on time to meet site metrics.
Job Description
- Required Competencies Demonstrable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.
- CQV project lifecycle experience from design through to C&Q and handover.
- Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.
- Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation.
- Experience in leading, managing and execution of FAT activities. 100%
- Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on time performance.
- Excellent communication skills and the ability to influence others.
- Demonstrable experience working in teams in a matrix environment to deliver CQV elements.
- Previous experience with electronic validation platform (e.g. ValGenesis, Kneat).
- Required Qualification(s) and Desired Experience The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with a minimum of 5 years of experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience.
