Job Description
QP release and certification of all assigned products within the EU & other relevant markets; assuring that the DP batch has been manufactured and checked in accordance with the requirements of its MA and in accordance with the principles and guidelines of GMP & any other legal requirements.
Product Certification & Release should be performed in accordance with 2001/83/EC (as amended) and 2001/82/EC (as amended).
QP and batch release activities should be in accordance with EU GMP Annex 16: Certification by a Qualified Person and Batch Release.
Identify deficiencies in product quality and quality systems.
Review and approval of Annual Product Quality Reviews for assigned drug product.
Ensure that all deviations and OOS results are investigated with timely CAPA (Corrective Action Preventative Action).
Review, manage and report adverse events for the EU and other relevant markets to health authorities.
Review, manage, report and coordinate product complaints and recalls for the EU and other relevant markets to health authorities.
Review and approval of completed laboratory control records, specification and procedures for tests performed on the IMIL site for assigned drug product.
Maintenance and review of QP register.
Maintenance of Quality Technical Agreements (QTA(s)) associated with assigned DP activities.
Review and approval of changes to laboratory equipment, documentation and methods at the assigned site. Review and approval of critical and major change controls at assigned manufacturing site.
Support the inspection process to ensure site conformity with regulatory authorities.
Management of sterile bulk drug product reference samples and retention of finished product samples for each batch released to the EU and other relevant markets
Trending of analytical data for critical quality attributes of sterile bulk drug product.
Contribute effectively to the site’s strategic development as part of the site management team.
Promote a site culture of total quality and enterprise excellence. Promote continuous improvement including sponsorship of programmes such as Lean Six Sigma.
Perform Resource planning to ensure that the group can support the business needs for strategic goals.
Responsible for the adherence to our Site Safety Culture by ensuring compliance with site EHS systems and procedures, completion of risk assessments as per department requirements, participation in relevant EHS unplanned events and ensure closure of EHS actions raised from accidents/incidents, audits, risk assessments etc. in a timely manner.
EDUCATION & QUALIFICATIONS:
Minimum:
BSc or equivalent in a sciences discipline, biology, chemistry, pharmacy or biochemical engineering.
Eligible to act as a Qualified Person as defined in 2001/83/EC (amended) and 2001/82/EC (amended).
4 years hands-on experience gained in a pharmaceutical laboratory with at least 2 years in a Supervisory position.
2 years as an active Qualified Person named on an MIA.
Language: English
Ideal:
MSc/PhD in a sciences discipline (biology, chemistry, pharmacy or biochemical engineering).
Eligible to act as a Qualified Person as defined in 2001/83/EC (amended) and 2001/82/EC (amended).
7 years hands-on experience gained in a pharmaceutical laboratory with at least 3 years in a Supervisory position.
3+ years as an active Qualified Person named on an MIA.
Language: English
For further information on this QP position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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