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Bimeda

Compliance Manager

Bimeda

  • Dublin West / Dublin South
  • Not disclosed
  • Contract
  • Updated 15/02/2013
  • Heather Darlington
this job is expired
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Description

Compliance Manager required for Pharmaceutical Company - 12 month contract

 

Job Spec: Compliance Manager (12 Month Contract)

Reporting to the Head of Quality – Cross Vetpharm Group Ltd, the purpose of this role is to lead the compliance function within the Company, ensuring that all processes are carried out in compliance with the internal, regulatory and statutory requirements.

Key Responsibilities:

  • Responsibility for the day to day management of the Compliance/ Quality Assurance functions within the Company.
  • Provide QA support for EU importation of pharmaceutical products, and batch release for the EU Market.100% Participation in Regulatory and Customer Audits.
  • Ensure a state of constant readiness for unannounced regulatory inspections.
  • Produce reports on the audits and ensure that appropriate CAPAs are implemented where necessary 
  • Responsibility for Management of the;
    • Change Control System.
    • Documentation Control System.
    • Deviation Control System.
    • Customer Complaint System.
    • Vendor Complaint System.
    • Internal Audit System.
    • Vendor / Contractor audit programme
    • schedule and participate in routine vendor audits and vendor qualification audits
    • Product Quality Review System.
    • GMP training programme.
  • Ensuring that all batch card QA review is scheduled, completed on time and logged
  • Review and approval of SOPs, SAMs, Artwork and SpecificationsResponsibilities for Contract Manufacture

Person Specification:

  • Bachelor’s degree in chemistry, biology, microbiology or a related discipline. An advanced degree in pharmaceutical science desirable.
  • Experience (5 years) working in pharmaceutical industry.
  • Experience should be in the quality assurance, quality control, compliance and/or manufacturing areas.
  • Thorough understanding of quality systems and cGMPs.
  • Experience with and fundamental understanding of EMA regulations and associated guidance documents
  • Experience leading GMP audits, including drug product manufacturing and analytical testing sites
  • Experience in finished product manufacturing, particularly sterile product manufacture desirable

 

  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, partners and colleagues.
  • A true self starter, who works effectively on their own initiative, and is used to working in demanding environments
  • Experience interfacing with regulatory bodies or working on regulatory submissions
  • Highly organised, with exceptional time management and prioritisation
  • Critical thinking and evaluation of process problems 

Please note: Only successfully shortlisted candidates will be contacted by phone for interview.

Ref: CMMK
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