You will lead and co-ordinate the activities of the QA Operations Team
Support the site with RCA and investigations , and event management
To ensure finished products are produced in accordance with internal and external quality regulations (US, European, ROW GMP’s and applicable regulatory filings.)
To ensure a robust system is in place to determine the acceptance or rejection of batches of finished products manufactured on the Cork site or subcontracted.
To support Key quality systems such as complaints, PQR’s, investigations, CAPA implementation and also support of key site programmes such as Virtus
To manage the activities of the QP’s and QA operations group ensuring development of personnel through goals and development plans and 1:1
To provide Quality Support for the Site and to contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
To make visible the run rate of the group to ensure capacity and org models are fit for purpose and efficiencies in BRR process are being realised.
Support Approval for all relevant quality documentation through QA Operations.
Review & approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required
Making sure that there is stability data to support retest or expiry date, storage conditions
Support inspections and audits from external parties (e.g. FDA, HPRA, etc)
Participating in internal audits as required
Participate in the preparation/review of regulatory dossiers as required
Establish and maintain support and key liason representative with key customers where we manufacture product
Requirements
You will have a relevant B.sc degree with 5 + years industry experience in a similar pharma environment
Ideally, you will have or been enrolled for further education to meet the requirements for position of Qualified Person as defined in Article 49 Directive 2001/82/EC
Demonstrated ability in the leadership, management and development of a team in a pharmaceutical area so that you can coach and mentor your team effectively
Experience of GMP auditing and documentation
Qualifications
B.Sc
Skills
Communication Skills
Management Skills
Quality Assurance
Quality Control
Quality Improvement
Teamwork Skills
Leadership Skills
Strong leadership Excellent communication Problem solver Analytical focus Strong listening & interpersonal skills
Problem-Solving Skills
Experience
5+
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