Pharmaceutical & Biotechnology
- Dún Laoghaire, County Dublin, Ireland
PE Global is currently recruiting for a Qualified Person for a leading multi-national Pharma client based in Dublin.
This is a 12 month contract position.
- Perform activities as required per company procedures as QA staff, and in particular where the role of QP is specified in the procedures
• Own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
• Perform review and approval of validation documentation.
• Lead and participate in internal and external audits as needed.
• Maintain a close contact and familiarity with the clients Quality systems and programs utilized at other client sites.
• Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
• Evaluates and assess change control records, non conformances and CAPAs.
• Participate in global Quality initiatives as a site subject matter expert.
• Participate or lead projects and improvement efforts including product launches.
• Supports the evaluation of quality and distribution complaints.
• Supports regulatory inspections or various questions from regulatory bodies.
- Relevant Experience working in the pharmaceutical or Biotechnology Industry over a minimum of 5 years OR minimum of 2 years experience as a practising QP.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Niamh on +353 21 4520313 or alternatively send an up to date CV to Niamh.firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***