Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans. Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product or material and assess potency, quantity, identity and safety against defined specifications.
The role of QC scientist (Operations) is 70% lab based and involves performing in process and release testing, leading minor quality events, identifying and implementing continuous improvement initiatives, executing validation/tech transfer protocols.
Please note that this is a full-time shift-based role. You will be working Sunday- Wednesday (06AM - 345PM, earlier / 1215PM - 10PM lates, bi-weekly rotation).
Key Responsibilities
1. Execution of analytical tests - in process drug product samples
2. Execution of analytical tests - release drug product samples (selected assays)
3. Execution of analytical tests - drug product stability samples
4. Laboratory housekeeping - maintenance of laboratory in inspection ready state
5. Reagent preparation (e.g., preparation of media, aliquots, controls)
6. Management of QC materials (e.g., media preparation, aliquoting, stock management)
7. Operation and maintenance of analytical instruments in accordance to governing SOPs
8. Participation in execution of qualification scripts (IOPQ)
9. Conducting root cause analysis using appropriate tools
10. Initiation of deviation, laboratory investigation, change control or CAPA as required
11. Performing impact assessment for minor deviations and minor change controls
12. Leading internal QC investigations forming part of deviation, laboratory investigation
13. Defining and implementing effective CAPA within QC
14. Ownership of minor internal QC change controls
15. Data entry / collation for tracking and trending purposes
16. Review of QC records
17. Preparation of calculating spreadsheets following guidelines
18. Archiving of GMP records
19. Completion of GMP documentation in accordance with ALCOA/data integrity requirements
20. Designing GMP documentation (e.g., logbooks, forms)
21. Managing GMP documentation (logbooks, worksheets, documentation trackers)
22. Timely completion of own quality events
23. Designing worksheets
24. Preparation of high quality SOPs using approved templates (general QC procedures)
25. Preparation of certificate of analysis
26. Participation in tech transfer, validation / verification of analytical methods
27. Any other duties as required following consultation with the post holder
28. Work in adherence to local Health and Safety policies and SOPs
Demonstrated Skills and Competencies
E – Essential
P – Preferred
Experience
1. Minimum 5 years’ experience within a QC laboratory, without BSc/MSc degree in life sciences
2. Minimum 2 years’ experience within a QC laboratory, with BSc/MSc degree in life sciences
3. No minimum industry experience, with a PhD in life sciences or relevant subject
Qualifications
BSc/MSc degree in life sciences or significant relevant industry experience
Skills/Specialist Knowledge
1. Soft skills (effective written and spoken communication, organisation, teamwork) (E)
2. Ability to precisely follow instructions and procedures (E)
3. Open to working shifts (E)
4. Attention to detail (E)
5. Meet requirements to work in cleanroom environment (E)
6. Good technical writing skills (P)
7. Ability to design high quality documents and presentations using Office 365 tools (E)
8. Good knowledge of statistics (calculation of mean, median, standard deviation, %CV), interpretation of statistical analysis results (e.g., t-test, confidence intervals) (E)
9. Reporting of numerical values – significant figures, decimal places, rounding in the context of generating and reporting results (E)
10. Understanding of method performance parameters (e.g., precision, accuracy, linearity, range, LOQ, LOD) (P)
11. Understanding of analytical method validation, verification and tech transfer process (P)
12. Familiarity with relevant regulations governing Quality Control function (e.g., EudraLex, ICH, FDA CFR) (P)
13. Working knowledge of Quality Management System records (e.g., deviation, CAPA, laboratory investigation, change control) (P)
14. Working knowledge of aseptic technique and cell culture methodology (E)
15. Good understanding of principles of analytical instrumentation
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