- Reference: CJ45187
- Job Type: Permanent
- Location: Munster, Tipperary, Waterford
- Category: Science, Pharmaceutical & Food
QC Team Leader – Pharmaceutical Multinational
- To lead and supervise all activities associated with their quality control stream and ensure all such relevant activities comply with all GMP, GLP, EHS and regulatory requirements.
- Ensure QC team work in a safe manner and in accordance with Good Laboratory Practices.
- Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements.
- Ensure Adherence to all safety standards – “Lead by Example”.
- Read and understand Standard Operation Procedures applicable to role.
- Report all accidents, incidents and any EHS issues using the appropriate process /system to your manager or, if required, the Occupational Health Advisor.
- Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
- Be aware of the impact of your job activities on EHS.
- Conduct formal / informal safety audits / checks including safety contacts on a daily / weekly basis and ensure appropriate actions are identified to avoid reoccurrence and all identified actions are closed in a timely manner.
- Report any damaged or unsafe equipment or practice.
- Ensure that there is adherence to the garbing procedure and proper use & maintenance of PPE.
- Ensure all Risk Assessments are completed to schedule and that any new risks are identified and escalated to your manager immediately.
- Ensure EHS audit findings are thoroughly investigated and effective corrective and preventive action plans are in place to prevent a re-occurrence. Ensure timelines are adhered to.
- Generate Accident Reports & participate in Accident / Incident investigation where required.
- Chair weekly EHS meeting as per schedule and support monthly meetings as required.
- Ensure safety culture is embedded within the QC area.
- Ensure near miss target is achieved as per site scorecard.
- Escalate issues to the QC Manager as appropriate
- Manage the area during any unforeseen situations such as accidents/incidents, chemical Spillage’s, etc.
- Ensure QC team work in a compliant manner and in accordance with Good Manufacturing and Good Laboratory Practices.
- Ensure all quality audit findings are thoroughly investigated and effective corrective and preventive action plans are put in place to prevent a re-occurrence. Ensure timelines are adhered to.
- Be aware of the impact of your job activities on quality.
- Training of QC team in accordance with GLP.
- Review of completed analytical reports prior to OQ approval.
- Preparation, review and approval of in-house procedures e.g. SOPs, monographs, protocols etc.
- Decision-making and liaison with internal departments to disposition product in accordance with GMP.
- Troubleshooting analytical problems.
- Participate fully in our site’s quality initiatives and support quality continuous improvement programmes.
- Communicate with the QC Manager on a regular basis on QC status.
- Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device Products/Markets.
- Provide motivational and effective leadership for team members.
- Manage training and development plans for direct reports. Monitor personnel performance, time keeping and attendance and provide regular updates to the QC Manager.
- Responsible for direct supervision of the following activities:
- Sampling and testing activities relating to raw materials, packaging components, bulk product, finished product, stability and validation ensuring lead-times are adhered to
- Ensure there is a balanced workload among analysts
- Manage holiday applications and holiday cover
- Ensure thorough understanding of HR legislation and policies.
- Ability to provide key input into site management decisions.
- Building capability in team.
- Drive accountability within the team.
- Educated to a minimum of primary or higher science based degree level.
- 3-4 years’ experience in a pharmaceutical / healthcare industry in an analyst/ senior analyst / supervisory capacity.
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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