Basic Summary:
To manage a team and apply technical expertise in support of analytical testing on finished product & raw materials using the correct procedures to comply with cGMP, Health and Safety, SOP's and environmental and regulatory requirements while ensuring we meet our customer's needs.
This position reports to the QC Laboratory Manager
Key Responsibilities:
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 highest of standards with regard to data integrity and compliance with current guidelines.
Manage performance of analysts including annual reviews, ongoing development plans, time and attendance and training records. Achieve required testing schedules by assigning and ensuring team and individual KPI's are met, allowing the timely completion of testing as per the schedule to meet planned due dates.
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.
Ensure that continuous improvement initiatives are identified and implemented in the laboratory as appropriate.
Any other duties assigned by the QC ManagerCompetencies:
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 and working knowledge of the most common analytical techniques and relevant softwareString attitude to the ALCOA+ requirementsAbility to build relationships and collaborate with others.
Excellent communication skills, both verbal & written.
Strong analytical ability and associated problem solving.
Flexible and show willingness to learn to develop technical skills.
Qualifications & Experience:
3rd level qualification – bachelor's degree in a science-based discipline.
Minimum of 5 years relevant experience in a pharmaceutical's environment.
People Management experience and ability to lead and motivate a team.
Strong computer skills in MS OfficeExperience working within a pharmaceutical cGMP Environment; with knowledge of EU GMP