Posted on Mar 15, 2019 by Anonymous
For the Manufacturing licence, act as a Qualified Person in accordance with EU Directive 2001/83/EC.
The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organisational, supervisory, technical writing and investigation skills are required.
For the Manufacturing license, act as one of the Company's Qualified Persons in accordance with EU Directive 2001/83/EC.
To act as the QP for one of the production plants.
Role of QP to include
Direct contact with relevant production Coordinator on GMP issues.
Cooperation with Production to ensure continuous improvement
Provide details on corrective actions required for batch deviations
Assist in the implementation of Quality Systems within production to ensure compliance with GMP
Provide regular feedback to other QP's on main issues for relevant production plant
To act as QA representative on major projects as required.
Communication / liaison with other departments.
Participate fully in any cross-functional training initiatives.
Participate in the vendor audit program.
Participate in the self-inspection programme.
To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required.
Maintenance of the Quality Systems within the business.
EDUCATIONAL REQUIREMENTS/RELEVANT EXPERIENCE:
Possesses suitable educational background that meets the requirements of Article 49 of Directive 2001/83/EC.
Have a minimum of five years' experience in the Pharmaceutical Industry in a QA role.
QP experience in solid oral dosage manufacture and/or packaging is preferable
Good organizational, investigational & technical writing skills are required
Be a self starter who is motivated & innovative
What the company Can Offer You
To further support and inspire our employees, our benefits include: To further support and inspire our employees, our benefits include: Talent & Development Programme, Flexibility, Occupational Health & Wellness Programme, Company Events, Health Insurance, Pension, Paid Maternity/Paternity Leave, Educational Assistance Programme, Performance Related Bonus, Zero Absence Award, Onsite Parking, and Onsite Canteen.
The acceptance of C.V's, interviewing or engagement by your organisation of a candidate introduced by Jacksonstone Recruitment Ltd shall be deemed to be an acceptance of our Terms and Conditions. Further copies of our terms are available at any time on request by email to your Account Manager. Terms and Conditions can only be altered by a Director of Jacksonstone Recruitment Ltd and any changes must be agreed in writing. In particular PLEASE NOTE that our guarantee period only applies if our invoice is paid in full within 14 days of the date of issue.
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Jacksonstone Recruitment Ltd. is registered in Ireland.
Company Registration No. (phone number removed)
Established in 1999 we recruit throughout Wicklow, Wexford and Dublin. Jacksonstone Recruitment span across a diverse range of clients from local SME clients to large multinational corporations in many sectors including Office Staff, Accountancy & Finance, Financial Services, Sales & Marketing, Customer Service, Retail, Production & Manufacturing, Biotechnology, Pharmaceutical Life Science, Supply Chain, Logistics, Quality Control, QC Analysts, Biochemist, Temp jobs, Contract vacancies and Permanent roles. See our website (url removed) for details of all our open jobs