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Quality Assurance & Regulatory Affairs Officer - Pharmaceuticals

Salary

£55,000 - £60,000

Location

Slough

Job Type

Full Time

Reference No: RI3349077633

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Job Description

This role has complete responsibility for the delivery of Quality Assurance and Regulatory Affairs for the affiliate. 

 

Responsibilities will include:

  • Representing the QA function within Quality leadership meetings, giving expert advice on strategies to maintain/improve quality performance
  • Ensures that the Affiliate is in line with the European Guidance on Good Distribution Practise (GDP) for all relevant products 
  • Constantly improving the Pharmaceutical Quality System and product quality
  • Regulatory compliance - write, review, develop, validate and maintain local regulatory SOPs in line with local regulatory legislation, guidelines, issues, practices and Corporate procedures  
  • Responsible for the management of release and updating of Summary of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) 
  • Responsible for product recall 
  • Knowledge of Quality Systems Management, GDP, GMP, GCP, Regulatory and Pharmacovigilance legislation where appropriate 
  • Experience with CNS, gastroenterology or oncology would be an advantage.
  • Effective investigations and analyses of issues are completed, and appropriate Corrective and Preventive Actions are identified and implemented
  • Facilitates the conduct of Risk Assessments and the development of Risk Mitigation Plans, and monitors mitigation actions
  • Launch, implements and manages a documentation system, able to fulfil legal and corporate requirements

 

For more information please get in touch with Natalie Hopkins via natalie@linkfieldgroup.com or phone         0207 183 5059

Applicant Requirements
  • Life Sciences Degree
Reference No: RI3349077633
Linkfield Life Sciences are a Regulatory Affairs Recruitment Partner, working with organisations across the Life Sciences sector.

Hiring Manager(s)

Natalie

Head of Regulatory Affairs Recruitment at Linkfield Life Sciences
email: natalie@linkfieldgroup.com

Email Natalie

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