As a member of the auditing team the post holder 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 key function of this role is to minimise the risk to the company by ensuring a high level of compliance is being adhered to for outsourced work. The post holder will be the lead for auditing and associated activities in our contract manufacturer sites in India and other territories on a regular basis; this will require travel to these regions approximately 40% 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.
- Carry out 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
- Participate in regular team and group meetings
- Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required.
- Educated to degree level or high, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical).
Knowledge and Skills:
- 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.
Additional Knowledge and Skills:
- Proven external auditing experience
- Proven 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.
- Responsible sourcing experience while an asset is not essential as training will be provided
- Excellent communication skills with ability to communicate at all levels within the organization
- 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.
- Ability to work independently and make decisions based on judgement and integrity
- Proven analytical skills and ability to transfer findings into well written report formats
- Experience / training in problem solving and process improvement methodologies
- Ability to work effectively independently and with others to accomplish goals in a challenging environment
- Excellent organisational and time management skills
- Demonstrates and understands customs and beliefs of various groups or cultures. Understands how these differences affect performance and communication
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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