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Job Details: QA Manager

RFT Group
Established in 1997, The RFT Group has an unrivalled track record in recruiting for our clients throughout Ireland.We are privileged Preferred Suppliers in recruiting for leading companies who have; jobs in biopharmaceutical, clinical research, diagnostics, medical devices and jobs in pharmaceutical multinational corporations.
We are the dominant recruitment agency in the rapidly expanding indigenous sector, recruiting in partnerships with Enterprise Ireland, Forfas and Science Foundation Ireland supporting vacancies with newly established spin out companies.
Our team comprises senior consultants who are all degree qualified in science, engineering or human resources and possess strong customer service experience and have strong experience in recruiting for jobs in science, engineering, pharmaceuticals, medical devices, biopharmaceutical, human resources. All recruitment consultants possess strong customer service experience.
QA Manager
The QA Manager is responsible for ensuring that all of the quality systems are appropriate so that the product safety, efficacy and quality are maintained for these Contract Manufacturers.

Also required to ensure that contract manufacturing sites maintain compliance with the local and international regulations, as per markets supplied. Products include; sterile, liquid, solids and API’s.

Responsibilities of QA Manager - Contract Manufacturing:
Write Technical Quality Agreements to align Contract Manufacturers with the company, thru legal contracts.
Implement program management process to support compliance initiatives of the Contract Manufacturers.
Travel to off-site Contract Manufacturers locations to ensure quality systems are aligned to Technical Agreements.
Work with Ops and clinical trial programs insure regulatory filing submissions.
Provide Quality support for the Contract Manufacturers, for new products introductions or filings.
Ensure regulatory approvals are obtained, with no delays to the market entries.
Provide quality support for product transfers to/from associated Contract Manufacturers.
Provide quality and compliance support for finished dosage forms, product manufacturing, packaging and labeling of the Contract Manufacturers
Drive complaint trend investigations for non-medical and medical complaints.
Ensure the appropriate GMP requirements are met for the validation of; product, process equipment and facility.

Requirements of QA Manager - Contract Manufacturing:
Bachelors Degree in Science, Engineering or other technical/scientific area. Master Degree preferred.
Proven Auditing experience in pharmaceutical industry. Preferably; QP or Quality Certification.
8+ years in QA, Ops or Technical experience in pharmaceutical manufacturing of; sterile, liquid, solids and/or API’s.
Project management and troubleshooting skills.
Strong communication & influencing skills, ability to manage & motivate a team.
Experienced in Quality troubleshooting / tools for fact base decisions making.

We need : English (Fluent)

Type: Permanent
Payment: Not disclosed
Category: Health

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