Main Duties & Responsibilities
This job description gives a general outline of the duties of the post and is not intended to be an inflexible or finite list. It may therefore be varied so that changing needs of the service can be met, in consultation with the post holder.
Documentation:
1. To comply with the organisation’s Documentation Policy.
2. To ensure all documentation associated within QA and QC activities are recorded contemporaneously and is clearly written.
3. To maintain the documentation control system in accordance with cGMP
4. Review batch documentation and verify records are in accordance with cGMP principals.
5. Generate and control batch documentation and other relevant documents to meet regulatory and business needs.
6. To approve and assess manufacturing records.
7. To escalate any rejected batches to senior management and participate in investigation of any quality issues.
8. Generation and updating of Raw Material Specifications, Product specification.
9. Review certificate of analysis and other relevant testing documents from supply/manufacturer (contacting suppliers over discrepancies).
10. Revise, review and write new SOP’s or update existing procedures in timely manner.
11. To Maintain material release and testing log.
12. To Maintain product quality data and trending of analytical results.
13. Prepare quarterly environmental report for senior management to review.
14. Writing annual summary for environmental data and report to QA manager
15. Review and maintain MSDS data for all the raw material
16. Build and maintain microbial data library.
17. To Participate in reviewing raw data generated during routine testing, method development, method validation, and transfer. Ensure accuracy and proper interpretation of results.
18. To Plan, perform, and coordinate stability studies for new and existing products, including review of stability protocols and reports.
19. To Prepare, review, and update relevant SOPs as required.
20. Review and maintain all equipment, instrument, and activity logs as per defined schedules.
21. Organize and ensure timely PPM and calibration of all instruments.
22. Perform and participate in out-of-specification (OOS) and failure investigations.
23. Prepare, review, and update relevant SOPs as required.
Quality:
1. Visual inspection of finished products
2. Visual inspection and checking integrity of raw material and consumables on receipt
3. Raw material sampling and organising or performing testing
4. Reporting test results to QA for approval to release the material
5. Releasing of raw materials to production for use once they met with set criteria
6. Facilitating microbial monitoring for site as per the set frequency
7. To perform environmental monitoring of the facility and to report all environmental monitoring data to the relevant personnel in a timely manner.
8. To ensure all finished product and raw material samples are sent to the contract laboratories in a timely manner and results are obtained within the expected time frame
9. Archive released product worksheets, monthly filing of all facility logs and product supply records
10. To initiate, review and assess quality exception reports, change requests and complaints
11. Perform impact assessment of QER and change request
12. To prepare and perform qualification of various equipment’s used in analytical lab
13. Participate in investigation of out of specification test reports
14. Perform and participate in routine monitoring and maintenance of equipment used in analytical lab
15. To maintain ongoing supplier management program
16. Review and release finished product as per the final release procedure
17. Participate in recall exercise and support QA to investigate
18. To identify areas for continuous improvement within the organisation and take a lead to drive the process improvement. To be a role model for others.
19. Update and review of daily /weekly temp recording (Including stability data)
20. To update chemical excel sheet after usage of bottles
21. Raw material and receipt of inspection
22. RM and PV sampling
23. initiate the QER
24. Update RM specification or Write new one
25. Consumable stock take on monthly basis
26. Visual inspection of Finish product and Send sample to external laboratory
27. Stability sample pull, update the schedule and log
28. Incubate the plates and register in the log
29. Microbial Environmental monitoring
30. Spray, wipe and hand accreditation
31. Resolve issue/ problem and to support QC scientist during their daily work
32. RM Quarantine area management
33. To perform Cleaning validation sampling
34. Handling of Control drugs
35. To attend meeting and update QC team - Procurement supply update
36. Calibration and usage of FTIR, density meter
37. Support Quarantine area management
38. Calibration of IR (Monthly)
39. Preparation RM specifications
40. Update SOP's related to Raw material management, training and logs
41. Handling CD materials
42. Train New personal on Raw material activities
43. Responsible for product inspections timelines and report timelines for inspection to Bova team
44. To share monthly report for stability studies - products studies initiated, completed, terminated, monthly stability target achieved
45. Maintain cleanliness and organization in both wet and dry laboratory areas.
Training:
1. To draft and execute training materials for all BOVA staff members.
2. To maintain all training records and review training files on periodic basis.
3. Perform periodic peer observations of various team members for critical process steps and report your observations to department managers
General skill Set required by Bova:
1. Minimum education to a degree or NVQ 3 level in Science related discipline or equivalent;
2. Demonstrate an ability to read and interpret documents which relate to health & safety and regulations, operating and maintenance instructions, and procedure manuals;
3. Demonstrate an ability to calculate basic and advanced figures which may include, but are not limited to, discounts, solutions strengths, concentrations, proportions, percentages, weights and volumes;
4. Must demonstrate an understanding of the importance of time management, following instructions and organisational skills;
5. Must possess exemplary computer skills and knowledge and be able to adapt to and learn any new computer software that may need be implemented;
6. Have an ability to follow complex, multistep procedures and processes
7. Must be able to execute the physical demands required for this role including manual handling of equipment and materials;
8. Must demonstrate a willingness to work with chemicals in knowledge of potential side effects, and must ensure that all staff follow the procedures to ensure safe handling of hazardous chemicals;
9. Must demonstrate an ability to conduct complex procedures in an environment in which the noise level may be moderate, and be accurate and prompt;
10. Must demonstrate an ability to perform repetitive work within a busy manufacturing environment
11. Must have professional telephone etiquette skills for communicating with customers and suppliers
12. Must demonstrate excellent communication skills with other staff, suppliers and customers
13. Must be able to work on a multi-departmental level within the organisation to accomplish the overall business goals
14. Respond to correspondence (phone, email, mail or other) in a timely and efficient manner;
15. Other reasonable duties as assigned by senior management on an ad hoc basis.
Job Type: Full-time
Pay: £35,000.00-£37,000.00 per year
Benefits:
- Company events
- Company pension
- Cycle to work scheme
- Private dental insurance
- Private medical insurance
- Referral programme
Work Location: In person
