Job Description
This newly created Dublin based role requires an experienced Quality Manager in drug development for a highly rewarding permanent appointment.
Our client is a multinational biopharmaceutical company with an outstanding track record of innovation in their specialist therapeutic sectors. The company has a strong pipeline of drug compounds at an advanced stage in research.
The Quality Manager will provide day-to-day technical QA support to the CMC operations team onsite as well as at the contract manufacturing sites in support of product manufacturing, release testing and stability studies.
The Quality Manager will reports to: Director of QA (GMP)
Responsibilities:
Perform technical reviews from Quality perspective and ensure CMO?s compliance with manufacturing and testing procedures and specifications in support of release and stability testing
Author and review Standard Operating Procedures (SOPs), batch records, and specification documents relating to the manufacture and testing procedures of starting materials, reference standards, drug substances, and drug products
Prepare certificate of analysis for QA product release
Review/Approve all analytical procedures or specifications impacting the identity, strength, quality, and purity of the components, in-process materials, and final product
Write and review SOPs related to QC function
Assist in preparation of CMC sections of regulatory submissions as requested
Establish and implement stability program procedures for cell banks and final products. Write stability reports as necessary to establish product shelf-life
Review and approve technical documentation, ensuring accuracy, clarity, and quality. protocols, test reports, stability reports, technical reports, and SOPs
Review and evaluate all release and stability data to ensure compliance with established specifications for all aspects of the product
Serve as technical lead for laboratory related investigations and provide support for process investigations as needed. Maintain compliance with cGMP regulations, and quickly resolve discrepancies
Assist with validation activities, evaluating and trending of release and stability data, and assisting in any analytical/laboratory issues/investigations
Maintain databases and documentation for tracking stability samples inventory and QC retains
Conduct and review supplier audits as requested
Other duties as assigned
Travel 5-10 % as requested
Requirements:
BS.C in health science or medical field or equivalent
8+ years of experience in the pharmaceutical or biotechnology industry
Maintain up-to-date knowledge of current analytical and laboratory practices including a current understanding of USP/EP, cGMP regulations, ICH and FDA Guidance Documents.
QP status or studying for QP status an advantage
For further information on this QC Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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