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Quality Assurance Specialist
Job Description
*Depending on experience
The QA will provide quality support and oversight of the commissioning & qualification and process qualification of the facility, utilities, computer systems and equipment. They will collaborate cross-functionally to ensure project timelines and milestones are met.
Primary Responsibilities:
• Support the Quality oversight associated with Commissioning & Qualification (C&Q) and validation activities for site. These activities will involve facilities/utilities, equipment/systems, computerized systems, process and validation maintenance.
• Perform quality review of documents to support facility commissioning and qualification, according to project timelines.
o Commissioning / Qualification Protocols
o Performance Qualification Protocols (PQ)
o Review and Approval of protocol discrepancies
o Review of Final Reports and Summary Documents
• Provide quality support during execution of commissioning and qualification testing, reviewing and approving changes and discrepancies, as required.
• Ensure that all activities & related documentation for facilities, equipment, materials, and processes comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
o Ensure documents comply with procedures, regulatory expectations (e.g., FDA, EMA), and Good Documentation Practices (GDP).
• Provide timely feedback and collaborate with authors and engineers to address document gaps or discrepancies.
• Participate in meetings related to document planning, execution, and issue resolution.
• Escalate any compliance concerns or critical gaps to QA management.
• In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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