Operational Quality Manager/QP
Operational Quality Manager/QP in leading pharma company based in Co Tipperary. Reporting to the Head of Quality, this role The Operational Quality Manager/QP will act in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of the company products.
The Operational Quality Manager/QP plays a key role on site and will sit on the Quality Leadership Team.
Responsibilities will include
- Manages the batch disposition process to ensure timely release of company products.
- Ensures the batch disposition process maintains compliance with site practices & regulatory requirements.
- Disposition of Pinewood Healthcare products and materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
- Support major investigations, ensuring all product deviations are closed prior to batch release.
- Reviews and approves Product Quality Reviews.
- Reviews and approves new and revised master manufacturing records.
- Participates in cross-functional teams as Quality/Qualified Person representative.
- Participate in third party/supplier audits, as required.
- Review annual customer complaints.
- Participation in any product recall or product defects.
- Actively contribute to continuous improvement initiatives.
- Conduct duties in a safe manner and report all safety issues and concerns.
- Complete all duties as per relevant SOP’s.
- Review of investigation reports.
- Review of validation protocols.
- Review of Quality Documentation as appropriate e.g. Bill of Materials etc.
- Work with relevant departments to ensure timely closure of Quality Actions / Findings.
- Provide additional QP support to quality related issues, as required.
The Ideal candidate will have:
- Must meet the minimum training/education requirements for QP qualification
- Must have at least 5-7 years’ experience working within a Quality Assurance role
- Work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) is highly desirable.
- Finished dosage formulation manufacturing experience is a requirement for the role
- Outstanding organisational and time-management skills.
- Ability to leverage/collaborate effectively with internal and external stakeholders
- Excellent written and verbal communication and interpersonal skills.
- Strong problem-solver.
- Independent, critical thinker with strong decision-making skills.
- Comfortable working in a busy, fast paced regulated manufacturing environment