Quality Auditor - Cork region - Pharmaceuticals
As a member of the auditing team the successful candidate 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 ensuring a high level of compliance is being adhered to for outsourced work. The post holder will be looking after the auditing and associated activities in our client's contract manufacturer sites over-seas on a regular basis; this will require travel to these regions.
- 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.
- Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary
- Educated to degree level or high, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical).
Knowledge and Skills:
- 5 + years pharmaceutical manufacturing experience in a similar type role
- Broad knowledge of at least one dosage form
- Laboratory 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.
- Comfortable presenting to different stakeholdersAbility to work effectively independently and with others to accomplish goals in a challenging environment
If this sounds of interest to you or you would like to find out more information don't hesitate to get in contact today on 021 2300 300
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.