Job Description
The Quality Manager QP will be part of the Disposition team who are accountable for batch disposition for Biologics products manufactured at CMOs.
The scope includes Drug Substance, Drug Product and Finished Drug Product.
The Disposition team will work with our external CMO partners and internal Quality teams. In addition, this function works closely with External Supply, Supply Planning, Technical support and any stakeholders involved in external supply.
Key Accountabilities
Reviewing batch documentation, data, certificates of analyses, technical reports and providing support to Quality Disposition personnel
Dispositioning batches in alignment with Quality Systems and GMP regulations
Managing, 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
Managing batch disposition processes as required
Makes batch disposition decisions in compliance with SOPs and GMP regulations
Evaluation of CMO’s Quality Management Systems to ensure the appropriate level and content of reporting, including technical evaluation of quality system reports
Evaluation of batch manufacturing records to determine assurances of safety, identity, strength, quality, or purity
Determining the impact of production/release schedule changes to commercial supply
On-going evaluation of batch review/release systems to ensure efficient and effective processes are implemented with integrated continuous improvement methodologies
You will manage continuous improvement initiatives in the batch disposition team and support continuous improvement initiatives in Biologics external supply
The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at multiple CMOs across the region
You will have detailed knowledge of general analytical chemistry, microbiology, cell biology, protein structure/function and analysis, and characterization assays.
Experience with commercial method implementation.
Strong working knowledge of USP, EP, ICH, cGMP, FDA and EU requirements and guidelines
Experience with lean processes
You will have a thorough knowledge of GMPs and Quality Systems
Clear, concise communication skills, both written and spoken
Demonstrated ability to interact professionally, to influence, and to manage conflict/differing opinions with the ability to drive solutions
Education, Behavioural Competencies
8 years’ + experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
Must be a QP and have experience in batch disposition.
You will have a strong technical/Quality background with specific experience in Biologics manufacture and batch disposition.
Must be a Qualified Person.
The manufacturing site experience would be valuable.
Thorough understanding of quality systems and GMPs.
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 available to travel -approx. 20% (domestic and international)
For further information on this Quality Manager QP Disposition 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
Follow us on Facebook, Linked-in, Twitter