Verification Lead
- United States
- Contract
- CAPEX Projects
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 14644, 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:
- A minimum of 10 years’ experience in the pharmaceutical industry including Capital Projects, C&V and People Management experience.
- Detailed knowledge of ISO 14644, 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
If this role is of interest to you, please apply now!
#LI-MC1
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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