OVERALL PURPOSE OF ROLE:
The prime objective of the Quality Control Specialist will be to ensure testing is performed in a timely manner. Ensuring the testing including investigations and write-ups are completed. Planning and ensuring that consumables are available for test and would not encounter a delay.
KEY ACCOUNTABILITIES OF ROLE:
Extensive experience working in Laboratory have good understanding of SDS, COSHH and Health and Safety regulations.
Perform Microbiology and Chemical testing of Pharmaceutical Products.
Have good understanding chemical and analytical testing of Pharmaceutical Products
Hands on experience in handling HPLC is an advantage.
Ensure that laboratory supplies (Microbiological and Chemical) are maintained at appropriate levels
Ensure that all routine testing (Microbiological and Chemical) is performed in a timely manner in line with agreed schedules.
Make sure that equipment used in testing are in calibrated state and maintained in line with SOP’s and manufacturers recommendations.
Writing and reviewing raw data, SOP’s and training programmes related to Laboratory operations.
Ensure all laboratory and other relevant procedures are compliant with cGMP, ICH and compendia requirements.
Provide technical support to Quality and New Product development team
Ensuring that all standard procedures are followed.
Initiating OOS / OOT investigations where required.
Completion of documents, protocols and reports capturing validation activities.
Completion of all test documentations and write-ups in line with Data Integrity principles.
Other duties as assigned.
Clear understanding of GMP, Eudralex, Orange Guide and Data Integrity.
Working knowledge of quality testing of pharmaceutical products.
Ensuring timely completion of product testing reports.
To co-operate and build strong working relationships internally and externally.
Providing technical support to new and on existing projects.
Demonstrate flexibility and willingness to assist.
Reliable & strong work ethic.
Ability to work as part of a team to achieve results
Ability to work independently.
To maintain professional standards at all times.
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
Degree related to microbiology or Bio science is preferred
Experience & Competences
Must have experience working in Laboratory
Checking and reviewing laboratory write-ups.
Capable of working to deadlines & remain calm under pressure
Must have experience working with method validation / transfer
Must have experience working with method development
Must have experience working with product shelf life testing.
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
Experience of routinely using ICH guidelines and EU GMP Chapter 6 (Quality Control)
Ability to perform routine simple and complex calculations
Enthusiastic and highly motivated
Positive attitude and flexible approach to work
Self starting and able to work on own initiative
Reliable and punctual