Senior Quality Assurance Analyst: Pharma Microbiology & GMP

Job Title Quality AssuranceAnalyst (Band 4)

MPA are currently recruiting a Senior Quality AssuranceAnalyst on behalf of our client, who is one of the leading authorities of regulating in the public sector.

The post holder will perform microbiological and analytical testing that includes chemical analyses, sterility testing, and environmental and product monitoring in accordance with the principles of cGMP (current Good Manufacturing Practice) and GCLP (Good Control Laboratory Practice) with knowledge of GMP and Good Laboratory Practice (GLP).

Hours of work: 37.5 hours per week (Monday to Friday)

Pay Rate: £14.06 PH

Location: Belfast

General Responsibilities:

1. Performs routine and non routine chemical, physical and microbiological analyses of raw materials, sterile and non sterile finished products, and packaging components, consumables and investigational medicinal products for Victoria Pharmaceuticals and hospital pharmacy departments.
2. Performs all tests necessary relating to stability and shelf life of products, including supporting product and service development within Victoria Pharmaceuticals and wider HSC Trust Pharmacy Departments.
3. Performs and determines the range of tests as are necessary in the testing of raw materials and finished products and assist in the research and development of new assay methods.
4. Ensures all laboratory testing undertaken, is performed in accordance with laboratory analytical specifications and SOPs.
5. Uses a wide range of complex analytical instruments including HPLC, IR Spectrophotometer, UV Spectrophotometer.
6. Reviews production batch documentation prior to release.
7. Performs complex calculations in determining assay results.
8. Performs water testing, both chemical and microbiological, on samples from Victoria Pharmaceutical Production Unit and regional hospitals.
9. Assists with performing daily, weekly and monthly calibration tests on laboratory equipment, in conjunction with Senior Analyst.
10. Executes all aseptic duties relating to the sterility testing of finished products from Victoria Pharmaceuticals, sterile samples from aseptic/cytotoxic departments and Pharmassure samples, and other microbiological analysis tests eg. Total Viable Counts, bioburdens.
11. Actively involved in correcting deficiencies raised at MHRA Inspections.
12. Participates and is actively involved in the Pharmaceutical Quality System which includes Out of Specifications, Investigation Reports and Customer Complaints.
13. Participates in the writing, updating and reviewing of all Quality Assurance documentation, including procedures and analytical specifications.
14. Performs investigational research requested from other hospitals on miscellaneous samples, documenting the work carried out and results in a QA report.
15. Maintains self training records and participates in Personnel Contribution Plans.
16. Involved with the training of analysts, ATOs and pre registration pharmacists in analytical testing, operating equipment and laboratory procedures. Responsible for updating staff training records.
17. Participates in a program of self inspection and audits within the department.
18. Communicates effectively and liaises with Production Staff, Store Staff and external customers both verbally and electronically.
19. Participates in the procurement process for the purchase of new laboratory equipment and then the commissioning of the equipment for use.
20. Actively deals with internal and external customers by various mechanisms (email, letters, telephone) on a range of technical and customer relations matters.
21. Assists with the quarterly laboratory testing of control drug active pharmaceutical ingredients.
22. Covers the duties of other staff during periods of sickness and absence undertaking any other reasonable duties commensurate with the grade.
23. Handles and moves goods and equipment (max 25kg) transferring between cages, trolleys, cupboards and work areas, and shelving that are on different levels.
24. Maintains and replenishes laboratory reagents, convol solutions, mobile phases etc used in the laboratory.
25. Participates in Pharmassure Laboratory test accreditation scheme.
26. Chairs QA meetings on a rota basis.
27. Undertakes any such duties as may be required according to the needs of RPQAS.
28. Assists in ensuring compliance with legislation relating to COSHH regulations Health and Safety at Work Act and local laboratory health and safety matters.
29. Complies with departmental policies and procedures concerning security, safety and confidentiality

Essential Criteria:

BTEC in Pharmaceutical Sciences or Applied Science or equivalence OR HNC

OR

NVQ Level 3 in Chemistry, Pharmaceutical Sciences, Microbiology or equivalent GCSE Mathematics and English (A-C) or equivalent.

Post holder must possess good procedure and report writing abilities with excellent, effective communication skills.

Team worker able to work to a high level degree of autonomy under pressure.

Demonstrates good time management, effective communication skills organisation and excellent prioritisation of duties.

Enthusiastic, focused and an ability to work to schedules and meet deadlines. Actively developing personal qualities.

Demonstrates basic knowledge of cGMP and GCLP.

Experience and knowledge of pharmaceutical microbiology.

Computer literate with good keyboard skills and the ability to create and maintain spreadsheets.