QA Compliance Auditor

We are seeking applications for a QA Compliance auditor to join a research driven Biopharmaceutical Company with a global presence. This role can be based at any one of our client's multiple bases in the EU.
 
Why you should apply:
 

• You are an experienced QA professional with at least 1 years Auditing experience


• You want to work for a progressive, forward thinking company who work every day to help people live better lives


• A clear career progression plan will be crafted with the successful candidate, to allow them to progress within the organisation


• This role is generously compensated, with an attractive base salary, bonus, healthcare & pension

 
 What you will be doing:
You will perform evaluations for compliance with US and foreign regulation requirements and provide constructive evaluation of quality related systems for suppliers that provide materials, services and products. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers, devices, specialty pharmacies, logistic providers and third party manufacturers.

• As QA Compliance Auditor you will be responsible for the assessing the compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and company specifications.


• You will provide feedback in the form of audit observations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier.


• You will participate in strategic initiatives to improve compliance to regulatory requirements and standards

What you need to apply:

• You will have a Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.


• You must have a technical background and understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.


• You will have demonstrated an understanding of a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.


• In this role, it is important that you have excellent oral/written communications skills.


• In addition, personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment.


• Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas.


• You will have 2+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device/nutritional or related industry (at least 1 year in compliance/auditing is required).  Total combined experience expected to be at least 6 years.


• ASQ certification desired, not required.


• Fluency in English is compulsory for this role and a 2nd language is preferred.


• This position will involve up 75% travel internationally.