Long term contract opportunity for a QA Specialist with a leading Limerick based Pharmaceutical company.
This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities, Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
- Responsibilities:
- Responsible for ensuring compliance with all aspects of Quality inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
- Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
- Collaborates with Cross functional teams to resolve issues, complete investigations and
- maintain compliance.
- Responsible for review and approval of the following types of documents: Failure investigations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP's), GxP documents,Change control documents
- May lead & support root cause analysis ensuring appropriate CAPA are implemented to
- prevent recurrence where relevant as a quality approver.
- Reviews procedures, policies and other instructional documents relating to quality
- systems to ensure compliance with company policy and local and international regulatory
- requirements.
- Monitoring and trending metrics associated with site quality systems.
- Actively participate in continuous improvement ideas, initiation, and implementation.
- May participate in internal, regulatory and customer audits.
- Skills, Attributes & Experience:
- Bachelors Degree in a scientific/technical discipline required
- A minimum of 3-5 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
- Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
