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Base Pay Range
Provided by BioTalent. Your actual pay will depend on your skills and experience — discuss with your recruiter to learn more.
Job Title
Senior Quality Assurance Specialist in Pharma and Biopharma - BioTalent
Location
London – Competitive Package
About the Role
BioTalent is supporting an ATMP organization in recruiting a QA Operations Specialist. You will play a critical role in ensuring GMP compliance in manufacturing operations, supporting the production of life-changing cell and gene therapies.
This role involves working Wednesday-Saturday or Sunday-Wednesday shifts, with a 13% shift allowance.
Key Responsibilities
* Provide quality oversight of GMP manufacturing activities to ensure compliance with regulatory requirements.
* Support batch review and release processes, including documentation review and deviation assessments.
* Participate in investigations of deviations, CAPAs, and change controls, ensuring timely resolution and continuous improvement.
* Conduct GMP audits and inspections of manufacturing areas, ensuring adherence to SOPs and quality standards.
* Review and approve manufacturing and laboratory records, including equipment qualification and validation protocols.
* Act as a QA liaison between production, QC, and regulatory teams to maintain high-quality standards.
* Support regulatory submissions and inspections (MHRA, FDA, EMA), ensuring readiness and compliance.
* Provide training and mentorship to manufacturing teams on quality and compliance best practices.
Requirements
* Experience in GMP quality assurance within a pharmaceutical or biotech environment, preferably in ATMP, cell therapy, gene therapy, or biologics.
* Strong understanding of GMP, GDP, and relevant regulatory guidelines (MHRA, EMA, FDA, ICH, Eudralex).
* Experience with quality systems such as deviations, CAPAs, change control, and batch record review.
* Excellent attention to detail, problem-solving skills, and ability to work in a fast-paced environment.
* Strong communication and collaboration skills, with cross-functional experience.
What’s in it for you?
* Be part of a cutting-edge biopharmaceutical company making a real impact on patients' lives.
* Work in an innovative and fast-growing ATMP environment.
* Competitive salary and benefits, including career growth opportunities.
* A supportive and collaborative team culture.
Apply now and advance your QA career with an exciting ATMP company!
Additional Details
* Seniority level: Associate
* Employment type: Full-time
* Job functions: Quality Assurance, Manufacturing, Science
* Industries: Pharmaceutical Manufacturing, Biotechnology Research, Medical Equipment Manufacturing
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