Department: QC Laboratory
Reports to: QC Laboratory Manager
MAIN PURPOSE OF ROLE:
The prime objective of the Assistant QC Manager will be to support the QC Laboratory Manager in managing and controlling of the QC Laboratory, maintaining files and documentation related to test data, equipment and results and providing technical expertise in support of the Quality Programme.
Key tasks of the role include updating SOP’s and facilities, ensuring the current version of all relating international standard / EU GMP standards is readily available at the laboratory, making sure all Pharmaceutical Quality Systems are implemented and all laboratory employees are informed with adequate training.
Other areas of responsibility include arranging installation, service and repairs of laboratory equipment, ensuring the safe disposal of chemical waste, assisting with Health & Safety compliance and improvements at all times.
Ensure that laboratory supplies are maintained at appropriate levels.
Ensure that all routine testing is performed in a timely manner in line with agreed schedules.
Make sure that equipment is appropriately calibrated and maintained in line with SOP’s and manufacturers recommendations.
Write and review SOP’s and training programmes related to Laboratory operations.
Support, training and advice to personnel working within Laboratories.
Ensure all laboratory and other relevant procedures are compliant with GMP, ICH and compendial requirements
Provide technical support to Quality and New Product development team
Ensure all procedures are within review dates.
Ensure that all procedures are followed.
Lead OOS / OOT investigations.
Lead, document and timely closure of deviations / CAPA / Change Controls
Perform Root Cause Analysis where required.
Lead Analytical Method Transfers (Approval of documentation / testing).
Lead Method validations (Approval of documentation / testing).
Generation of documents, protocols and reports capturing validation activities.
Managing and reporting laboratory performance.
Managing and planning stability programmes.
Lead and participate in project work as necessary by the business.
Other duties as assigned
1. Clear understanding of GMP, Eudralex, Orange Guide.
2. Thorough knowledge of quality testing of pharmaceutical products.
3. Managing timely release of products / results and investigations.
4. To co-operate and build strong working relationships internally & externally.
5. Providing technical support to new and on existing projects.
6. Demonstrate flexibility and willingness to assist.
7. Reliable & strong work ethic.
8. Ability to work as part of a team to achieve results
9. Ability to work independently and with multiple levels within the organization.
10. To maintain professional standards at all times.
11. To be punctual, maintain appropriate dress standards, be polite and courteous to internal and external customers at all times.
Educated to degree level in a relevant scientific subject or equivalent
Experience & Competences
Previous experience in a GMP laboratory management or facilities role in a scientific research or pharmaceutical environment
Strong leadership skills with ability to manage change & confront performance issues
Ability to continually adapt to rapidly changing regulated environment in a positive manner
Capable of working to deadlines & remain calm under pressure
Self directed and self motivated with ability to motivate & direct others
Knowledge & Skills
Excellent communication skills in English, both oral and written
Excellent understanding of GMP
Thorough knowledge of quality testing of pharmaceuticals & their materials
Superb inter-personal skills & instant credibility
Sound problem solving skills
Good organisation & time management skills
IT literate in Microsoft Software Packages,
Basic information relating to ICH guidelines and EU GMP Chapter 6 (Quality Control)
Ability to perform routine simple and complex calculations
Professional, methodical approach to work
Enthusiastic and highly motivated
Positive attitude and flexible approach to work
Self starting and able to work on own initiative
Reliable and punctual
“Can Do” attitude at all times
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