Job Title: Quality Assurance CSV Specialist (Projects) - Initial 12 month contract
PI Historian experience required
A pharmaceutical diagnostics manufacturing organization is seeking a detail-oriented and motivated Quality Assurance CSV Specialist (Projects) to support the Quality Assurance Lead / Manager (Project) and Quality Projects Lead in executing quality oversight activities for Capital Expenditure (CapEx) projects. This role will focus on the review and approval of Commissioning & Qualification (C&Q) documentation, and the development of quality policy documents based on strategies developed in collaboration with CapEx Leadership.
The successful candidate will have a solid understanding of GMP principles, computerized system validation (CSV) lifecycle, and quality systems in a regulated pharmaceutical environment.
Main Duties and Responsibilities:
The specialist will be responsible for providing QA support on projects including, but not limited to, the review and approval of qualification and verification documentation in accordance with project strategy. Responsibilities include:
* Reporting to and supporting the Projects Quality Lead in implementing the quality strategy for CapEx projects.
* Reviewing and approving CSV documentation including URS, DQ, IQ, OQ, PQ protocols and reports, ensuring compliance with internal procedures and regulatory expectations.
* Acting as the QA point of contact for automation-based and direct product contact control system projects.
* Drafting and revising quality policy and guidance documents aligned with project quality strategies and site-specific requirements.
* Participating in design reviews, risk assessments, and change control evaluations related to project activities.
* Collaborating with Automation, Engineering, Validation, and other cross-functional teams to ensure timely QA input and approvals.
* Assisting in tracking and resolution of quality issues, deviations, and CAPAs related to project deliverables.
* Maintaining accurate and organized QA records and documentation in accordance with data integrity principles.
* Supporting internal and external audits and inspections as required.
Desirable Skills:
* Strong knowledge of GMP regulations, ICH Q8–Q10, Annex 11, 21 CFR Part 11, and validation lifecycle principles.
* Familiarity with CSV processes, GAMP 5, and documentation in pharmaceutical manufacturing environments.
* Excellent technical writing and document review skills.
* Strong attention to detail and ability to manage multiple priorities.
* Effective communication and interpersonal skills for cross-functional collaboration.
* Proficiency in Microsoft Office and experience with electronic document management systems (EDMS).
Principal Qualifications & Experience Required:
* Experience with Pi Historian is essential
* A third-level qualification in a relevant Science or Engineering discipline; an advanced degree is preferred but not essential.
* Minimum of 4 years' experience in Quality Assurance within the pharmaceutical or biotech industry, including at least 3 years' experience in Computer System Validation (CSV) projects.
* Experience with capital projects, DCS,, SCADA, eBR, and BMS Validation is highly desirable.
* Familiarity with practical application of Quality Risk Management (QRM) and Risk-Based Verification (RBV) as per ISPE Commissioning & Qualification guidelines, GAMP 5, and risk-based decision-making is advantageous.
* Experience with digitized C&Q platforms such as Kneat or ValGenesis is a plus.
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