Quality Assurance Officer, Pharmaceutical Ftc

QUALITY ASSURANCE OFFICER, Pharmaceutical FTC
Location: Wimslow
Type: 6 month fixed term contract
Hours: Days (Monday - Friday), parking onsite
Additional: 25 days holiday + BH, private medical, share options scheme, company pension
Our Client a Biotech company is looking for an experienced QA Officer with a background in steriles.
This is for a period of six months & supporting their Head of Quality with associated duties- hitting the ground running.
The role:
• Generation or review of SOPs and other documents (where applicable)
• Providing support the customers and answering queries and product investigations
• Coordinate and resolve immediate/urgent customer complaints, ensuring prompt responses/ resolution
• Participate in the internal audit programme to ensure continued GMP compliance of all site activities
• Utilise scientific resources in order to work on improving quality of products and services
• To maintain personal training folder in an auditable state
• Maintaining quality documentation system
• Participate in quality improvement initiatives
• Supporting in the process or maintaining and archiving documentation
• Supporting and executing external audits where applicable
• Supporting management when hosting regulatory audits
• Working on executing and maintaining the QMS, including but not limited to:
ØRisk Assessments
ØChange Controls
ØCAPAs
ØDeviations
ØComplaints
ØRecalls
ØOOS/OOT
The Person:
• Will have a Degree in a relevant- Scientific discipline
• Will have good knowledge of GMP & experience in steriles is essential!
• Experience in CAPA, Deviations, OOS, OOT, Internal auditing (preferred), Customer Complaints handling would be very advantageous
• Strong IT skills (Microsoft applications)
• Good interpersonal skills and strong written/ verbal report writing skills
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