Job Reference: JO-2011-65449_1604316052
Excellent opportunity for candidates with strong people management within a lab setting to join our leading multinational client in Cork.
- Allocate the work of the department to the QC staff to ensure effective schedule adherence
- Supervise the work performed in the QC department and perform annual appraisals of QC staff while insuring up to date training and development
- Control products (raw materials, intermediates, and finished products) by following procedures (general, specific, of analysis and use, and qualification of equipment) so as to meet schedule demands
- Review analytical data and approve and release material as defined in relevant procedures
- Coordinate and manage equipment maintenance and repair activities
- Deliver operating budgets, ordering, and supervise expenditure
- Maintain an awareness of technical developments for instrumentation analysis and schedule training for the team as appropriate
- Perform investigations, and ensure a follow-up on anomalies, failures, and external complaints
- Implement and manage change control systems for QC activities including assessment of changes for impact and develop action plans
- Ensure appropriate procedures are in place by preparation and review of SOP's, methods, and specifications.
- Complete documentation reviews, reports, preparation, and trending activities to ensure compliance
- Ensure QC activities are executed as prescribed by in-house procedures and in compliance with requirements of cGMP and relevant safety standards.
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
- Prepare and review QC department reports and metrics e.g. monthly quality report, analysis trending reports, exceptions reports, KPI reports, etc.
- Communicate to senior management on key events and issues etc. via normal in-house reporting structure e.g. meetings, formal reports, etc.
- Develop technical specifications and project justifications as required
- Establish project schedule and key milestones
- 3rd level qualification in a relevant Science discipline.
- Minimum 4 years of analytical experience in the pharmaceutical industry with supervision experience essential.
- Proven track record in an analytical role. Must be expert in HPLC, GC, LCMS,
- GCMS, Automatic titration, Identification techniques.
- Strong knowledge of regulatory requirements.
- Proficient in using analytical equipment in the QC lab.
- Involvement in product transfers/method transfer experience preferred.
- Results-driven striving to meet all targets and metric standards as set by
- department/site and division leaders.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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