Job Description:
Client in the midst of a construction expansion project and now at the stage of Commissioning and moving into Qualification soon. Looking for resources from a QA standpoint who can review and approve of URS, FAT, IQ OQ PQ procedures for manufacturing equipment, facilities, and utilities. C&Q document review is what we need from a QA perspective. NOT looking for lab folks or pilot plant folks, looking for folks coming from pharma / bio who have QA Manufacturing experience. QA oversight of validation/qualification activities, huge plus if they have capital project experience.
Prefer GMP Quality experience with biological drug substance or drug product. Work will also entail review of master batch records, SOPs and investigations.
Skills:
Quality Assurance, Manufacturing, Review/Approval of Validation
Education Minimum Requirement:
• Bachelor’s and/or Master’s Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline. Will consider Associate degree if they have 7+years of relevant experience.
Required Experience and Skills:
• With Bachelor’s Degree, at least 5 years of experience in the pharmaceutical industry or highly regulated industry.
• With Master’s degree, at least 3 years of experience in the pharmaceutical industry or highly regulated industry.
• Experience with review and approval of URS, FAT, IQ, OQ, PQ for manufacturing equipment, facilities and utilities..
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
Preferred Experience and Skills:
• GMP quality experience with biological drug substance or drug product.
• GMP experience with qualification of equipment.
• Experience with Quality Risk Management.
• Project Management experience in a highly regulated industry.
• Experience with Kneat, SAP, Trackwise and/or GLIMS
NC: QA Manufacturing Specialist (CQV) (232651)
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