Description
Overall responsibility for all activities within the QC Laboratory, including Compliance, Stability Program, Raw material testing, and finished product testing and release. Ensuring compliance with Regulatory, GMP, Health and Safety, Chanelle Procedures and specifications, environmental standards, and meeting customer requirements.
Location: 5 days onsite in our Loughrea QC Laboratory
As our QC Lab Manager, your key responsibilities will include:
Compliance:
* Ensuring QC Compliance activities are performed as per scheduled action plans, with up-to-date documentation including SOP, COI, ECP, etc.
* Taking necessary actions for deviations and ensuring CAPA are completed and closed.
* Participating in internal and external audits.
* Evaluating trends within the QC laboratory and taking appropriate actions.
Laboratory:
* Planning and completing testing for timely release of materials and products.
* Verifying data for integrity and accuracy.
* Overseeing the QC stability program and investigating out-of-specification results.
* Supporting new product introduction and collaborating with production and shipping.
* Leading and motivating analysts to meet targets.
* Ensuring testing complies with EU and US regulatory requirements, with a focus on data integrity.
* Providing technical guidance on testing issues.
* Maintaining and calibrating laboratory equipment.
* Managing standards and controlled substances as per procedures.
* Investigating analytical errors and ensuring laboratory operates within budget.
Safety:
* Ensuring laboratory safety and compliance, coordinating safety activities with EHS.
Training:
* Ensuring staff are trained and competent, arranging further training to develop staff.
Skills & Competencies:
* Leadership, motivation, organizational, and communication skills.
* IT proficiency and knowledge of analytical techniques.
* Strong understanding of ALCOA+ principles.
* Relationship-building and collaboration skills.
* Analytical and problem-solving skills.
* Methodical and proactive approach.
Qualifications & Experience:
* Bachelor’s degree in a science discipline.
* 10-15 years in the pharmaceutical industry, with at least 5 in senior management.
* Experience in a cGMP pharmaceutical QC lab; EU GMP knowledge essential.
This position is only open to candidates with valid EU work authorization.
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