QC Laboratory Supervisor (Evening Shift)
Loughrea, Co. Galway
About Chanelle Pharma:
To manage a team and apply technical expertise in support of analytical testing on finished product & raw materials using the correct procedures in order to comply with cGMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
In this role, you will be reporting to the QC Laboratory Manager
- Manage a team of Quality Analysts and ensure that all testing is conducted in accordance with current EU and Pharmacopeial requirements.
- Plan, schedule and co-ordinate analysis testing within the team.
- Ensure the heist of standards with regard to Data integrity and compliance with current guidelines.
- Achieve required testing schedules by assigning and ensuring team and individual KPI’s are met. allowing the timely release of raw materials for use in manufacturing.
- Ensure timely review and approval of laboratory results, protocols and reports for finished product and stability.
- Provide technical guidance in the event of equipment failure, calibration failure, out of specification results and any other issues as appropriate. Ensure all laboratory equipment is maintained and calibrated.
- Perform detailed root cause investigations into out of specification results or any analytical errors that occur in the laboratory.
- Ensure method transfer activities are completed on time within the team..
- Ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations, and industry standards.
- Complete statistical trend analysis in accordance with current GMP/GLP requirements.
- Support Reviewers to Review all laboratory notebooks, records, chromatograms etc. to an acceptable GLP standard and up to date at all times.
- Manage consumables stock levels in the laboratory.
- Guarantee that relevant Working standard and Reference standard are always available and not expired.
- Assist the QC Manager in hosting Regulatory inspections and Customer audits.
- Ensure that corrective actions identified because of observations raised during regulatory & customer audits are implemented in a timely manner.
- Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy.
- Support QC Manager in Review and approval company standard operating procedures.
- Identify training and on-going development opportunities for laboratory personnel and training records maintained.
- Ensure that continuous improvement initiatives are identified and implemented in the laboratory as appropriate
Any other duties assigned by the QC Manager
- Strong Organisational skills, time management skills and the ability to prioritise competing demands.
- People Management experience and ability to lead and motivate a team .
- Strong technical skills of the most common analytical techniques and 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.
- Flexible and shows willingness to learn to develop technical skills.
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.
- 3rd level qualification – bachelor’s degree in a science-based discipline.
- Minimum of 5 years in a pharmaceutical’s environment.
- Strong computer skills in MS Office
- Experience working within a pharmaceutical cGMP Environment; with knowledge of EU GMP
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
• Manual Handling
WORK ENVIRONMENT: (e.g., Office, Production)
HOURS OF WORK
- 15:30 – 00:00 (Monday – Thursday)
- 15:30 – 23:00 (Friday)