Quality Engineer Pharmaceutical

Quality Engineer - Pharmaceutical

Position Description
As a member of the auditing team the post holder will be responsible for assisting the Auditor Supervisor 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 internationally and other territories on a regular basis; this will require travel to these regions approximately 50% of time.

Key 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 quality inspections of other third party service providers such as packaging sites and API manufacturing facilities.


• 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.


• Carry out healthcare 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.

Education

• Educated to degree level or higher, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical).

Experience

• 6+ years pharmaceutical manufacturing experience in a similar type role within a progressive multinational organization.


• Broad knowledge of sterile/injectables, solid dose manufacturing is important.


• Experience of API manufacturing is desirable, with considerable expertise in at least one pharmaceutical field

Knowledge and Skills

• Proven external auditing experience


• Proven internal auditing experience


• Lead Auditor accredited


• 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.


• 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 has an understanding of customs and beliefs of various groups or cultures. Understands how these differences affect performance and communication.

Environment/Physical Demands

• General office environment with onsite visits to manufacturing facilities and laboratories requiring travel to India and other foreign locations approximately 50% of the time.

If you would like further information you can contact: Brian Christensen | Tel: +353 (0) 1 685 4747