LSC has an exciting opportunity for a Qualified Person to join a leading pharmaceutical company in Cork.
This is is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture.
If you have a minimum of 5 + years of experience as a QP in a pharmaceutical or biotechnology manufacturing and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of biologic product.
Key Objectives/Deliverables:
- Disposition of products & materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
- Manage the batch disposition process to ensure timely release of products.
- Ensures the batch disposition process maintains compliant with site practices & regulatory requirements.
- Support investigations which have the potential to impact batch release.
- Reviews and approves Annual Product Reviews, validation summary reports, control strategy documents.
- Participate in the vendor audit program.
- Participate in the self-inspection program
- Assist in audit preparation for regulatory and customer audits and act as a member of the audit team as required.
- Participates in cross functional teams as Quality/Qualified Person representative.
- Provide additional QP support to quality related issues, as required.
Requirements:
- Qualified Person status achieved with a minimum of 5 years of relevant work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA) for biologic products.
- Requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for biotech pharmaceuticals for human use and a good working knowledge of manufacturing processes and validation activities used in the biopharmaceutical industry.
- .Experience in quality assurance including change control management, regulatory audits and APRs. .
- Experience with IMP's (Investigational Medicinal Products) desirable
- Good organisational, supervisory, technical writing and investigation skills are required
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a valid Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Kathy Gillen at LSC on 021 4777329 if you have any more questions about this role!
