QC Lab Manager

3 weeks ago

Loughrea Municipal District, Ireland Chanelle Pharma Full time

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 and environmental while ensuring customer requirements and needs are met.

Location: 5 days onsite in our Loughrea QC Laboratory

As our QC Lab Manager your key responsibilities will be as follows:

Compliance:
  • Ensuring that QC Compliance activities are performed as per the scheduled action plans, to ensure that the QC department has up to date documentation to complete processes and testing including, SOP, COI, ECP and other documentation.
  • Ensures that the necessary action is taken as per the procedural requirements when Deviations occur and that CAPA are completed and closed as required.
  • Actively participating in internal and external audits.
  • Evaluate and take action on trends within the QC laboratory.

Laboratory:
  • Ensure planning and completion of testing to allow for timely release of raw materials, in process samples, finished products, pilot batches and validation related samples.
  • Ensuring that all data verification is performed in accordance with requirements for data integrity and accuracy.
  • Oversight over the QC stability program, ensuring that the program is managed as per site and customer requirements, that out of specification results are investigated and that the necessary action is taken when required i.e. notification to authorities and customers.
  • Support the new product introduction process by ensuring new materials and products are tested as required by the relevant project plans and protocols.
  • Collaborate with Production, Planning and shipping to determine priorities for release.
  • Lead and motivate the analysts to achieve weekly / monthly targets and shipping dates.
  • Ensure that all testing is conducted in accordance with current EU and US regulatory requirements. Data integrity is of paramount importance and must comply with current guidelines. Ensure timely review and approval of laboratory results, protocols and reports.
  • Provide technical guidance in the event of any testing issue experienced including equipment failure, calibration failure, out of specification results, method issues or any other issues as appropriate.
  • Ensure all laboratory equipment is maintained and calibrated.
  • Ensure that standards, controlled substances are maintained, replenished and discarded as per the Chanelle procedures.
  • Assist in performing detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory.
  • Ensure the laboratory operates within the requirements of the Annual budget on a monthly basis.

Safety:
  • Overall responsible to ensure that the QC laboratory is maintained in a safe and compliant way to ensure that personnel are performing their duties in a safe manner.
  • Coordinate safety related activities e.g. risk assessments, safety training etc with the EHS department.

Training:
  • Ensure that all staff in the QC department are trained and competent to perform their duties.
  • Coordinate with internal and external parties to arrange suitable training with the ultimate goal of developing staff within the QC department.

Skills & Competencies:
  • Strong Leadership and People Management skills essential with demonstrated ability to lead and motivate a team.
  • Strong Organisational and time management skills and the ability to prioritise competing demands.
  • Strong IT and technical skills and working knowledge of the most common analytical techniques & relevant software.
  • String attitude to the ALCOA+ requirements.
  • Ability to build relationships and collaborate with others.
  • Excellent communication skills, both verbal & written.
  • Strong analytical ability and associated problem solving.
  • Takes a methodical, systematic and structured approach to organising work.
  • Positive and proactive person who is energised by having great responsibility.
  • Practical, action-orientated approach to managing priorities and teams. The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required and may be subject to change.

Qualifications & Experience:
  • 3rd level qualification – bachelor's degree in a science-based discipline.
  • 10-15 years in a pharmaceutical's environment of which at least 5 in senior or people management position.
  • Experience working within a QC lab within a pharmaceutical cGMP Environment; with knowledge of EU GMP essential.

This position is only open to candidates who already hold valid work authorisation for the EU.
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