QA Compliance Manager

HERO

Job Detail

Location Cork
Salary Negotiable
Posted
Role Type Permanent
Contact Emma Griffin
email quality@hero.ie

QA Compliance Manager

Apply Now

Job ID: JOB-12079
QA Compliance Manager

Location: Cork

Our client who is a pharmaceutical company want a QA Compliance Manager to join their Cork team on a Permanent basis.

In this management role, you will be responsible for the quality assurance compliance activities in the Cork Site. You will also lead the implementation and maintenance of quality assurance activities in compliance with the current GMP regulations.

Responsibilities 

  • Managing all QA Compliance Activities including the Site Document Controller / QA Administrator, and QA Compliance Specialists, project related resources as required.
  • Completing the Annual Appraisals of the QA staff.
  • Partaking of department budget management
  • Management of the electronic documentation system.
  • Ensure appropriate QA Reviews / Approvals of GMP documentation eg, SOPs, reports, methods, specifications, validation protocols etc.
  • Management of the Archive System of QA documentation.
  • Preparation of the Site for Regulatory Inspections and Internal Compliance QA Audits and management of same.
  • Preparing and reviewing QA department reports and metrics
  • Site Business Administrator for SolTRAQS – Exception Reports, CAPA, Change Requests, Planned Deviations, AudiQ and Customer Complaints.
  • Establish the requirements for conducting and documenting Site Management Reviews so as to ensure the suitability and effectiveness of the quality system.
  • Management and delivery of all QA Activities related to New Product Introduction. This includes ensuring QA Compliance in all phases of the NPI Projects – Feasibility, Demonstration and Validation and QP release as required.

Education & Experience:

  • Degree in Science or related discipline
  • Minimum 5 years in Pharmaceutical Environment
  • Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16 (not mandatory)
  • Experience of GMP Auditing and Documentation

For more information on this role in Cork please contact Emma Griffin on 086 0334325 quality@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

Emma Griffin

JOB-12079

Apply Now

QA Compliance Manager

Emma Griffin

Role Type Permanent
Contact Emma Griffin
email quality@hero.ie
mobile +353 86 033 43 25
linkedIn profile click here

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