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Details

Quality Auditor


Reference:JO-A006761 Location: Cork
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Auditor

QUALITY AUDITOR

THE ROLE:

  • This is a key member of the auditing team, working closely with the Auditor Manager, ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. The key function of this role is to minimise the risk to NorthStar by ensuring a high level of compliance is being adhered to for outsourced work.
  • You will be the lead for auditing and associated activities in our contract manufacturer sites in India, China, and some European territories; this will require travel to these regions approximately 40% of time.


RESPONSIBILITIES:

  • Lead and conduct quality inspections of outsourced manufacturing facilities, including, but not limited to, solid dose finished product manufacturing facilities and sterile finished product manufacturing facilities to ensure compliance with cGMP and US FDA regulations.
  • Lead and conduct responsible sourcing inspections of outsourced manufacturing facilities as per company guidelines.
  • Lead and conduct quality inspections of other third-party service providers such as packaging sites, API manufacturing facilities and contract laboratories.
  • Compile inspection reports to include findings, corrections and process improvements.
  • Track corrective actions and planned action agreements from inspections to closure.
  • Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites with particular emphasis on process systems and QMS.
  • Carry out the company's business and compliance due diligence exercises.
  • Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties, as necessary.
  • Keep the Management team and colleagues updated on issues and actions which impact the business.


REQUIREMENTS:

  • Educated to degree level or higher, e.g. a minimum of BSc (biological or chemical sciences) or BEng (process and chemical).
  • 6+ years pharmaceutical manufacturing experience in a similar type role within a progressive multinational organization.
  • Broad knowledge of at least one dosage form e.g. steriles/injectables or solid dose manufacturing is important.
  • Experience of laboratory, with considerable expertise in at least one pharmaceutical field.


PREFERRED EXPERIENCE:

  • Proven external and internal auditing experience.
  • Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment including ICH guidelines and CFR part 210 / 211 regulations, 21 CFR Part 11 regulations.
  • Solid understanding of Quality Management Systems.
  • Solid understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process, etc.
  • Demonstrate ability to lead customers to improve performance or effectiveness; including the ability to influence through effective communication and diplomacy.
  • Ability to compile and made presentations at external sites to senior management level.




If you would like further Information you can contact the recruiter directly:



James Oakes | Tel: +353 (0) 1 507 9258