Location: Cork Role: Permanent
Global Generic Pharmaceutical company.
Reporting to the Compliance & Audit Manager, you will be responsible for internal & external cGMP & cGDP compliance.
You will assist in the organizing and completing of supplier audits for new and existing pharmaceutical finished dosage forms and medical device manufacturing sites, monitoring of suppliers performance, investigation of supplier issues and support the release of finished product.
You will also assist in the co-ordination and maintenance of new and existing Quality & Pharmacovigilance agreements with suppliers.
Must be willing and available for international travel as required and be eligible to apply for visas to the following countries: U.S.A., Canada, India, China
BSc in a scientific discipline preferred; minimum of five (5) years in a cGMP facility with Production, Quality Assurance or Quality Control experience.
Must have completed a Lead Auditor course or equivalent and should have experience in auditing in an international environment. .
Excellent oral and written communication skills
Ability to effectively manage and participate in cross-functional problem solving teams
Good investigative and error-spotting skills
Strong leadership skills and ability to lead cross-functional teams
Ability to develop and maintain cooperative working relationships with others
Good problem solving skills to evaluate quality problems and apply knowledge to identify appropriate solutions.
Excellent knowledge of Quality Assurance, GMP, Laboratory Systems and regulatory affair
Be willing and available for international travel as required (approx. 40%)