Senior QA Officer, Pharmaceutical
Location: Bolton/ North Manchester area
Type: Permanent
Hours: Days (Monday - Friday), parking onsite

Responsibilities:

• Duties will include handling site quality issues including compliance, validation, internal audits, project management & execution, and quality documentation, under the leadership of the Quality Assurance Manager.
• This role involves overseeing the quality of all products manufactured or sourced by the company to ensure adherence to GMP, GDP, and documented procedures.
• Additionally, the role supports Quality Management in implementing GMP/GDP documentation and in enhancing the Quality Management System (QMS) for continuous improvement.
• CAPAs, Deviations, audits, risk assessments, customer complaints & root cause analysis.
• Generate SOPS and other quality documentation.
• Ensure that the QMS is already in a condition ready to inspect.
• Ensure that the internal audit schedule is followed as per procedure.
• Manage and maintain the supplier approval process
• Create supplier audit documentation
• Liase with MHRA relating to quality and compliance matters.
• Assist in training of QA team members aswell as potentially helping to support other teams.
• Undertake and develop risk assessments.

The Person:

• Good knowledge of GMP/GDP related pharmaceutical manufacturing
• 3 years+ GMP experience in a similar facility
• Experience in CAPA, deviation, change controls, OOs, Oot etc
• Demonstrated compliance with procedures and policies
• The ideal Candidate will have auditing experience (desired)
• Excellent team, interpersonal skills, and communication skills (both written and verbal)
• Willingness to work flexible hours
• Safe adoption of working practises together with an understanding of the needs for precise and accurate documentation

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