Job Description
Our client, a blue-chip global BioPharma company, now seeks a Quality Operations Manager to ensure that contract manufacturing sites maintain compliance with the local and international regulations, as per markets supplied.
The Quality Assurance 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.
This is a permanent role, based in Dublin. Attractive package on offer for the successful candidate.
Responsibilities of Quality Assurance Manager:
Ensure 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 labelling 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 for Quality Assurance Manager:
Bachelor?s Degree in Science, Engineering or other technical/scientific area. Master Degree preferred.
Preferably; QP or Quality Certification.
8+ years in QA, Ops or Technical experience in pharmaceutical manufacturing for finished dosage forms or drug product.
Manufacturing related experience in some of the following areas: sterile, liquid, solids or API?s
Project management and troubleshooting skills.
Strong communication & influencing skills, and ability to manage & motivate a team.
Experienced in Quality troubleshooting / tools for fact base decisions making.
Please contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Key words; QA Manager, Quality Management, Quality Assurance, QP, Contract Manufacturing, Compliance, Auditing, Solid Oral Dose, Tabletting, Pharmaceutical, Biopharma, Biologics, Dublin
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