A QA Specialist – API is required by CareerWise Recruitment to join our based Co Cork based Biopharma manufacturing client.12-month initial contract role.
ROLE
* Quality Assurance Specialist provides support to all quality activities at Contract Manufacturing organizations (CMs).
* Ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
* Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
* Escalate quality issues at CMs to QA management.
* Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
* Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
* Coordinate and perform QA responsibilities of API shipments.
* Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
* Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
* Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
REQUIREMENTS :
* BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
* Large molecule / Bio experience with a minimum of 5 years’ experience required.
* Experience with external or 03rd party manufacturers would be a distinct advantage.
* Thorough technical understanding of quality systems and regulatory requirements.
Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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