|Contact Name:||Laurentina Kennedy|
Our client is a major multinational biopharmaceutical company with an exciting drug portfolio driving double-digit growth, creating highly attractive new career development and advancement opportunities at their globally-focused Dublin city HQ.
Quality Specialist will be accountable for batch disposition for Biologics product manufactured at CMOs. The scope includes Drug Substance, Drug Product and Finished Drug Product.
The Quality Specialist will work with our external CMO partners and internal Quality teams within this department. In addition, this function will work closely with External Supply, Supply Planning, Technical support and any stakeholders involved in external supply.
Reviewing batch documentation, data, certificates of analyses, technical reports and providing support to Quality Disposition personnel.
Evaluating, designing and implementing quality systems relating to batch disposition.
Maintaining and improving quality metrics that incorporate continuous improvement methodologies.
Facilitating, approving and providing inputs into deviation investigations, change controls, CAPA, investigations and nonconformance reviews as required.
Supporting batch disposition processes as required.
Education, Behavioural Competencies and Skills:
6 + years’ experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
Thorough understanding of quality systems and cGMPs.
Experience conducting audits and/or involvement in preparation for Health Authority inspections.
Interpersonal skills and communication skills to interact with CMO partners and other functions.
Must be able to prioritise in a busy environment.
Must be able to travel up to 20% (domestic and international)
Must be fluent in English
For further information on this QA Specialist 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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