Quality Assurance Officer - Pharmaceutical

Quality Assurance Officer - Pharmaceutical

£38,500 - £42,500 per annum depending on experience

Birmingham

Days - Monday to Friday

Permanent

Our Birmingham based client, a UK leader in their field, are looking to recruit a permanent 'Quality Assurance Officer - Pharmaceutical'.

The role:

• You will support the team's efforts to be 'GMP and GACP compliant' in an efficient manner. This will involve participating in all GMP and GACP related activities and preparing all necessary documents for inspection and ensuring the facility, equipment etc is compliant with the relevant regulatory guidelines.
• This role will also strongly support all ongoing quality initiatives and activities in line with MHRA requirements and expectations.
• This is an important position within our clients business to help spearhead their GMP journey.

Quality Assurance Officer - Pharmaceutical responsibilities:

• To monitor and report to the management group compliance against the key aspects of the Quality Management System
• Manage the Quality Management System including deviations, CAPA, change control, and standard operating procedures (SOPs)
• Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
• To investigate product complaints and generate investigation reports
• Act as a key person for pharmacovigilance queries in the absence of the Quality Manager
• Assist in the coordination and performance of internal quality audits as required
• External (MHRA)/Customer Audits: Lead preparation activities and responsible for backroom activities during external/customer audits.
• Deputies for the Quality Manager as and when required, i.e. attending meetings in their absence
• Vendor qualification of suppliers in line with the internal processes.
• Process validation, cleaning validation and transport validation, equipment and utility qualification.
• Lead the review, approval and release of SOPs, Instructions, Forms, Batch Production Records and testing data.
• Coach and mentor team members on quality assurance and business requirements including best practices.

Quality Assurance Officer - Pharmaceutical requirements:

• Proven experience in a Quality driven role in Pharmaceuticals with a good understanding of UK regulatory market:
  • GMP (including MHRA inspections)
  • GACP
  • GDP
• Experience of managing a quality team highly desirable
• Degree (or equivalent) in a Scientific discipline
• Good understanding of manufacturing drug substances (ideally including herbal products).
• Good understanding of good agriculture and collection practices.
• Proficient in MS Office
• Excellent communication skills (verbal and written)
• A good eye for detail and ability to meet strict deadlines
• Always looking to improve QMS performance

Please apply in the first instance with a copy of your CV.

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