Quality Officer job at Abacus Pharma

Description

Abacus Parental Drugs Limited is hiring a Quality Officer (3) responsible for execution of QA activities.

JOB IDENTIFICATION:

Department: Quality

Reporting to: Quality Assurance team leader-IPQA

JOB ROLES AND EXPECTATIONS:

Key Result Area

Key Roles/Duties

Quality

1. Schedule, prepare protocol/reports, and conduct process and cleaning validation.

2. Provide ongoing training, motivation, coaching, support, and correction to employees to ensure that quality standards are met.

3. Responsible for investigation of complaints and recalls in coordination with other departments.

4. Issue controlled documents, e.g., specifications, BMRS, CAPA forms, Deviation reports, QC reports, preventive maintenance forms, facility layouts, SOPs, protocols, etc.

5. Collect and compile statistical quality data, keeping accurate record of the same (APQR).

6. Monitor cleaning of warehouses, temperature mapping, and environment monitoring.

7. Document and report quality issues to the team leaders and section head.

8. Verify the received materials on receipt and ensure that they adhere to the defined standard specifications.

9. Preparation of documents required for regulatory affairs.

10. Monitoring and control of the manufacturing environment.

11. Checking of overprinted details and proof checking.

12. Line clearance during product changeover.

13. Compliance of audit observations.

14. Ensure basic norms of cGMP are being followed at all times.

15. Ensure availability and implementation of updated and approved SOPs in manufacturing, quality control, Engineering and warehouse areas. This includes conformance of activities with SOPs and any need to modify.

16. To check the cleanliness of the shop floor and auxiliary area.

17. Countercheck the in-process parameters.

18. Ensure calibration of equipment/instruments is regularly done.

19. Ensure the manufacturing process is validated and carried out as per instructions in the BMR.

20. Ensure health, safety, and environmental norms are being followed.

21. Check status labels and labeling of containers, equipment, and materials.

22. Online documentation and timely entries of all operations/activities.

23. Participate in validation, qualification, and performance verification.

24. Perform quality assurance rounds (Gemba walks).

25. Review and verification of different logs of production, packing, and store areas.

26. To review the finished goods receipt (BSR), storage, control, and dispatch.

27. To participate in external calibration and thermal mapping as per schedule.

28. Ensure that FEFO and FIFO are followed.

29. Perform sampling of bulk and retention samples.

Health and safety

1. Identify, assess, prioritize, and control risks arising from operations/activities in relation to the impact on the health and safety of all staff, contractors, and visitors.

2. Ensure that the work environment is safe and any health and safety risks are documented and followed by all staff through appropriate toolbox talks.

MINIMUM QUALIFICATIONS / REQUIREMENTS:

BSc. Degree in chemistry, pharmacy, or a related field.

Any experience in a pharmaceutical/healthcare industry is an added advantage.

TRAINING REQUIREMENTS:

Basic safety training

Basic GMP training

Good documentation practices training

• Schedule, prepare protocol/reports, and conduct process and cleaning validation.
• Provide ongoing training, motivation, coaching, support, and correction to employees to ensure that quality standards are met.
• Responsible for investigation of complaints and recalls in coordination with other departments.
• Issue controlled documents, e.g., specifications, BMRS, CAPA forms, Deviation reports, QC reports, preventive maintenance forms, facility layouts, SOPs, protocols, etc.
• Collect and compile statistical quality data, keeping accurate record of the same (APQR).
• Monitor cleaning of warehouses, temperature mapping, and environment monitoring.
• Document and report quality issues to the team leaders and section head.
• Verify the received materials on receipt and ensure that they adhere to the defined standard specifications.
• Preparation of documents required for regulatory affairs.
• Monitoring and control of the manufacturing environment.
• Checking of overprinted details and proof checking.
• Line clearance during product changeover.
• Compliance of audit observations.
• Ensure basic norms of cGMP are being followed at all times.
• Ensure availability and implementation of updated and approved SOPs in manufacturing, quality control, Engineering and warehouse areas. This includes conformance of activities with SOPs and any need to modify.
• To check the cleanliness of the shop floor and auxiliary area.
• Countercheck the in-process parameters.
• Ensure calibration of equipment/instruments is regularly done.
• Ensure the manufacturing process is validated and carried out as per instructions in the BMR.
• Ensure health, safety, and environmental norms are being followed.
• Check status labels and labeling of containers, equipment, and materials.
• Online documentation and timely entries of all operations/activities.
• Participate in validation, qualification, and performance verification.
• Perform quality assurance rounds (Gemba walks).
• Review and verification of different logs of production, packing, and store areas.
• To review the finished goods receipt (BSR), storage, control, and dispatch.
• To participate in external calibration and thermal mapping as per schedule.
• Ensure that FEFO and FIFO are followed.
• Perform sampling of bulk and retention samples.
• Identify, assess, prioritize, and control risks arising from operations/activities in relation to the impact on the health and safety of all staff, contractors, and visitors.
• Ensure that the work environment is safe and any health and safety risks are documented and followed by all staff through appropriate toolbox talks.

• Organization skills – oversee all quality assurance procedures and coordinate production processes.
• Effective leadership, coordination, and motivation skills are vital
• Good analytical and problem-solving skills.
• Confidence
• Excellent technical skills
• Planning and organization skills
• Effective verbal and written communication and interpersonal skills
• Problem-solving skills
• Team working skills
• Respect for others
• Result-oriented
• Open and Decisive.
• Teamwork

• BSc. Degree in chemistry, pharmacy, or a related field.
• Any experience in a pharmaceutical/healthcare industry is an added advantage.
• Basic safety training
• Basic GMP training
• Good documentation practices training