Excellent opportunity for a Quality Professional (Pharma) to move into Auditing
I am currently working with a leading international supplier of generic pharmaceutical drugs, who are based in Cork and are looking for a Quality Auditor to join their team on a Permanent Basis. These products are manufactured at established facilities that are registered with the U.S. Food and Drug Administration (FDA).
This company is not seeing any slow down in the current climate and are busier than ever with year on year business growth. They are actively seeking an experienced individual for this role and interviews will happen over video in the coming weeks
As a member of the auditing team you will be responsible for assisting the Auditor Manager in ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations The successful candidate will be helping to ensure a high level of compliance is being adhered to for outsourced work. You will be looking after the auditing and associated activities in the client's contract manufacturer sites over-seas on a regular basis; this will require travel to these regions approximately 30% of time.
- 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.
- Keep the Management team and colleagues updated on issues and actions which impact the business
- Educated to degree level or high, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical).
Knowledge and Skills:
- 3+ 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.
Additional Knowledge and Skills:
- Auditing experience required
- 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.
- Responsible sourcing experience while an asset is not essential as training will be provided
- Demonstrate ability to lead customers to improve performance or effectiveness; including the ability to influence through effective communication and diplomacy
- Demonstrates and understands customs and beliefs of various groups or cultures. Understands how these differences affect performance and communication
Work Environment/Physical Demands:
- General office environment with onsite visits to manufacturing facilities and laboratories requiring travel to India and other foreign locations approximately 30% of the time.
If you are interested in this role please click the 'apply now' button and I will be in contact with you. If you would like to find out more then give Kellie a call on 021 2300 412
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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