Verification Lead
Quanta part of QCS StaffingMichiganjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionA minimum of 10 years’ experience in the pharmaceutical industry including Capital Projects, C&V and People Management experience. Detailed knowledge of ISO , EU GMP Annex 1 and US FDA Aseptic Processing guidelines for Controlled Environments. Proven knowledge of C&V methodologies and current industry guides and practices. Strong capability to collaborate with system stakeholders, including C&V, Engineering & Automation personnel. Strong communication skills (verbal and written) and the ability to articulate ideas to influence others. Good problem solving / troubleshooting skills. Experience with BMS Automation systems. Good team member. Proficient in spoken and written English
Classified Environments Verification Lead - Michigan - 12-Month Contract
Do you want to work with an exciting company who are an established market leader within their unique and niche field? We have a fantastic opportunity for a Classified Environments Verification Lead with 10 years experience to drive the delivery of a large new capital invest project on an initial 12-month contract. As a Classified Environments Verification Lead you will play a key role in the successful delivery of a new state of the art facility.
Responsibilities :
- Preparation of all Verification Documents for the Facility, Qualified Areas, Isolator and Laminar Flow Units. This will include Risk Assessments (SRA) / Design Qualification (DQ) Reports) / Sampling Plans / Verification Test Protocols (VTPs) / System Acceptance and Release Reports (SARR) - per the project schedule.
- Ensure that all documentation required to complete all C&V activities for their area is prepared in advance of field need dates.
- Participation in Safety Management for the systems within their remit during System Start-Up & Commissioning execution – including Risk Assessments / Method Statements / Permitting / Lock-out Tag-out (LOTO).
- Coordination, management, and execution of Functional Commissioning activities. Functional Commissioning activities include Final Balancing / Differential Pressure Verification / Drawing Walkdowns / Documentation Verification.
- Development of Risk Assessments and Sampling Plans, as per ISO , for the testing of ISO 5 Isolators, and ISO 7 and ISO 8 Clean Rooms.
- Oversight of Verification Field Execution activities. This will include resource management (C&V / Automation / Quality Control (QC) / Vendor / Operations) and test equipment and consumables management.
- Sign Permits, as the Verification Phase Owner, for all activities on the systems within their remit during Verification.
- Ensure Vendor RAMS (Risk Assessments / Method Statements) are approved for works to proceed.
- Oversight and support of Vendor SAT activities including SAT protocol pre and post approval.
Required Skills and Experience :
If this role is of interest to you, please apply now!
LI-MC1
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Verification Lead • Michigan