This multinational pharmaceutical and biotechnology corporation is one of the largest producers of therapeutics in the world, with upwards of 70,000 employees and revenues above 10 billion per annum. In recent years, this market leader has expanded its footprint in Ireland, to not only include significant manufacturing operations, but additionally has started housing a number of key global roles responsible for the organisation's contract manufactured product portfolio.
As a result of additional CMOs coming online, this world leader now requires a remote/hybrid working,
Senior End RA/QA Contractor
within the organisation's External Quality/Regulatory Group. Aside from its Reg responsibilities, this role will also serve as the Quality interface between the Contract Manufacturing Operations, Quality and internal Reg Affairs dept.
Responsibilities
* Support Post Approval Changes, initial registrations and/or renewals.
* Review & assess the changes affecting ESOQ managed CMOs by performing regulatory impact assessment in collaboration with Regulatory Strategists as needed.
* Assume ownership of changes as described in associated change control procedures and processes to ensure timely progression of activities to support change completion.
* Act as a liaison between CMOs, VSOTs, sites within the Global CMC organization, Regional Strategist (if required) or Country Offices.
* Raise Change Management eQMS records, facilitate PAC creation and discussion within the VSOT, and open regulatory Product Change Form (PCF) for CMO or company initiated Post Approval Changes with potential regulatory impact.
* Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, and BOH queries from CMOs and GS sites as required.
* Monitor and notify the CMO and VSOT through the escalation process of regulatory submission status, BOH queries, commitments, and approvals.
* Act as a regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints if applicable.
* Act as regulatory expert for CMO liaising with Reg Affairs and supporting systems.
* Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required and involve the CQL appropriately.
* Actively contribute to SQRT/AQRT and support investigation into regulatory discrepancies and any other relevant support as needed for the role.
* Support APR providing list of relevant regulatory commitments/list of variation for the product/API within specified review period.
Experience
* Minimum Bachelor of Science Degree, Pharmacy, Engineering, or related technical discipline.
* Minimum 5 years' experience in Pharmaceutical or Bio RA/Quality Assurance roles.
* Experience with external suppliers/contractors.
* Advanced computer skills for MSOffice and enterprise systems such SAP, QTS, Vault.
* Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives.
* Demonstrated experience managing complex quality and compliance activities.
* Demonstrated knowledge of US, European and global cGxPs, compliance issues, inspectional trends, industry quality assurance practices.
* Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on for a confidential discussion.