Quality Assurance Manager

Location
Gloucestershire
Salary
Competitive salary and benefits
Posted
28 Apr 2021
Closes
05 May 2021
Ref
2903QAMGDP
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

DETAILS:

  • Full-time permanent position
  • Office based in Gloucestershire
  • Competitive package
  • Global pharma company

 

THE ROLE:

  • Ensuring compliance with Company QA and GDP requirements.
  • Ensuring consistent implementation of the QMS across the Company, including proactive management of:
  • Initial qualification and ongoing/periodic validation of suppliers
  • Initial qualification and ongoing/periodic validation of customers
  • Change control
  • Deviation management and Corrective Action and Preventive Action (CAPA) management
  • Customer and supplier complaints
  • Capturing key performance indicators (KPIs)
  • Training (GDP training as well as other non-pharmaceutical related training programmes)
  • Establishing, maintaining and controlling relevant Standard Operating Procedures (SOPs)
  • Quality Risk Management
  • Product Recall
  • Record management and document retention
  • Stock management practices
  • Pre-distribution internal batch checks
  •  
  • Providing QMS support to the Medical Affairs, Finance and Commercial departments
  • Maintaining ongoing ISO 9001:2015 and ISO 14001:2015 certification
  • Coordinating the communication and investigation of manufacturing deviations and product quality complaints.
  • Control and preparation of PQRs.

Full job description available on application

 

THE CANDIDATE:

  • A degree in Pharmacy, Chemistry, Biology or a Biomedical Science.
  • A demonstrable commitment to continuous professional development through self-directed learning and completion of appropriate training courses.
  • Significant experience in the pharmaceutical industry, with solid knowledge and experience in the quality and compliance of medicines. A knowledge of injectable medicines would be useful.
  • Proven experience of implementing/managing quality systems in a GxP environment.
  • Integrity and application of sound professional judgement
  • High levels of organisation and attention to detail with the ability to prioritise, plan and organise work in line with customer and business needs.
  • Effective communication of information (written and verbal) at levels appropriate to the needs of healthcare professionals, regulatory bodies, business partners, internal customers and the general public.
  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.