Quality Control Manager
5 days ago
**Job title**: Quality Control Manager
**Location**: Dublin
**Package**: Pension, Healthcare, Dentalcare, Shares
**The Company**
The company is a global biopharmaceutical company that specialise in treating patients with rare diseases. The company markets a portfolio of medicines through its orphan, primary care and rheumatology business units. The company's global headquarters arein Dublin, Ireland. The company also has offices in the US and Europe.
**The Position**
Reporting directly to Director, Quality Control, the Quality Control Manager is part of the quality team responsible for ensuring the highest quality standards for the product portfolios by providing oversight and management of operational elements of thePharmaceutical Quality System (PQS), which includes, but not limited to, metrics/KPIs, Change control management and regulatory compliance.
**Responsibilities**
- Oversight of assigned product testing, methods and investigations, including monitoring, tracking and reporting Quality KPIs.
- Support method transfer and validation from analytical development to commercial contract test laboratories.
- Building authentic relationships and leading QC related business meetings and audits of contract test facilities.
- Evaluate proposed changes to analytical methods, including conducting regulatory impact assessments.
- Responsible for timely management of OOS/OOT investigations, deviations and Change Controls related to Quality Control at contract test labs.
- Review analytical and stability sections of BLA/IND as required.
- Perform the monitoring and trending of analytical data for release and stability, implement corrective action plans where necessary and provide updates to senior management.
- Support in-process and final specification system for drug substance and drug product.
- Review proposed changes to systems, procedures, methods, and submissions to Health Authorities, as appropriate.
- Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
**Qualifications and Skills Required**:
- Bachelor's degree in chemistry, biology or a related discipline is desirable.
- Be well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales
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