Quality Manager, QP
|Contact Name:||Larry O’Leary|
Our client, a healthcare manufacturer based in Connaught, now seeks a QP who will provide support to the Director of Quality in addition to the Operations Manager in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements (i.e. FDA, EU and regional health bodies, etc.).
Scope of this role: QA oversight of all activities for the business ensuring the necessary GMP requirements are upheld.
The successful candidate will hold responsibility for certifying all batches manufactured in the business against the requirements of it?s marketing authorisation and the principles of GMP. The QP is legally responsible for batch disposition and must be listed on the company?s manufacturing authorisations.
Responsibilities for Quality Manager, QP:
Assist the Director of Quality and Operations Manager the delivery of the company quality plan and global regulatory requirements providing appropriate, timely information as required.
The QP will approve all records generated by the business unit, including but not limited to batch records, laboratory certificates of analysis, deviations, validation documents and product quality review reports.
Anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry.
Motivate the Operations employees to ensure all activities are performed in a GMP compliant manner through effective communication.
Provide direction to all quality personnel based in business, including QC, Product Release, Compliance and Microbiology.
Provide guidance to all operations functions to ensure activities are completed in a GMP compliant manner.
Provide quality input for proposed process changes within the business, manage quality requirements for NPI and quality KPI?s.
Represent the company in all inspections, ensuring the unit is audit-ready. Ensure any non-conformances and open commitments related to the business unit are addressed.
Evaluate and disposition all batches manufactured in the unit.
Provide guidance on all non-conforming material/deviated batches. Direct the investigation and determine the release disposition of such material/product.
Participate in the business unit APEX activities providing quality input.
Direct the activities of the QA and Product release personnel within the business unit to ensure product is released and activities are undertaken in a compliant manner.
Co-ordinate QMS Management.
Requirements for Quality Manager, QP:
Degree in a Pharmaceutical Science and recognised QP qualification.
Proven track record in a quality discipline in the Pharma/Medical Device environment, working FDA and cGMP.
Establishing excellent working relationships with all functions within operations and QA management team.
Excellent communication and presentations skills, both written and oral.
Excellent analytical skills, with proven ability to plan and schedule.
Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
Please contact Larry on +353 (0) 1 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. For a list of all our current vacancies, view our website http://www.rftgroup.ie/
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Key words: QP, QA Manager, Quality Assurance Manager, Qualified Person, Quality Assurance, Operations Management, Batch Release, Biopharma, Pharmaceutical, Medical Devices, Connaught, Galway, Mayo, Sligo, Roscommon.