Senior Executive/Asst.Manager

Ultra Laboratories; Hassan; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Ultra laboratories, Inc. is seeking a senior Quality Assurance leader to drive cGMP implementation, regulatory compliance, and risk management.

The role focuses on developing and maintaining the Quality Management System, SOPs, and document control across all manufacturing activities. You will lead investigations into deviations, CAPA closures, and supplier qualification while ensuring product quality from raw materials to finished goods.

Qualifications

• Experience in cGMP-compliant pharmaceutical environments.
• Proven ability to implement and maintain Quality Management Systems.
• Strong track record of regulatory audits and CAPA closure.

Responsibilities

• Lead cGMP implementation and regulatory compliance planning.
• Develop and execute Quality department strategy to meet business needs.
• Maintain Quality Risk Management system and regulatory alignment.
• Improve departmental performance in quality, service, lead time and cost.
• Develop, revise and approve SOPs and validation protocols.
• Ensure all activities comply with GMP, SOPs and safety policies.
• Build and maintain Quality team structure and training.
• Authorize specs, testing procedures, and quality documentation.
• Approve corrective actions and change controls.
• Oversee validation, IQ/OQ/PQ and process simulations.
• Authorize master records and quality system documents.
• Evaluate vendors and perform quality assurance checks across batches.
• Investigate OOS/OOT, incidents and deviations; handle customer complaints.

Skills

GMP implementation

Regulatory audits

Quality management

CAPA

Change controls

Document control

Vendor qualification

OOS/OOT investigations

Risk management

Education

Bachelor's degree in Pharmacy

Pharma quality systems training

Tools

QA/QC software

Validation protocols

Job description

Role & responsibilities

1. Responsible for cGMP implementation & ensure that every day system to be updated & to be maintained as per regulatory standards. Responsible for regulatory audits & compliance. Responsible for corrective actions and Preventive actions proposed during the Regulatory Audits. Ensuring that there is an audit program in place which is communicated to Operations.

2. Developing and implementing the Quality departments strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.

3. Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements.

4. Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.

5. Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being fit for purpose operationally and commercially.

6. Ensuring that all activities are performed in accordance with GMP, company SOP and Health and Safety policies.

7. Identifying and developing the Quality team structure. To plan, develop & implement quality systems in the Organization & ensure that the product quality is of good standards.

8. Authorization of specifications, standard testing procedures and general test procedures of Raw materials, Excipients, Packing materials, In-Process, Semi-Finished Product and Finished Products.

9. Approval of Corrective actions proposed for deficiencies occurred. Evaluation and approval of changes proposed in the facility and disposition of the same.

10. Approval of Qualification (DQ, IQ, OQ, IOQ & PQ) protocols and reports. Approval of Validation (Process/Cleaning) protocols and reports. Approval of process simulation study (Media fill) protocols & reports.

11. Authorization of Master Manufacturing records, Master Packaging records, Batch manufacturing records and Batch Packaging records. Prepare Quality system documents like Site master File, Validation Master Plan, Quality Manual.

12. Evaluation and Qualification of vendors of APIs, Primary packaging materials, Critical Excipients and Critical Consumables. Monitoring of In-process Quality Assurance checks. Review the reports of Plant Quality Management review.

13. Ensuring the investigation of OOS, OOT, Incidents and deviations are appropriately performed and documented. Investigation of Customer Complaints/ Product Recalls/Returned goods. Notifying about regulatory/customer inspections to all the departments and accompany for inspections.

14. To ensure that manufacturing and other operations are carried out as per the procedures laid down in the MMR’s & SOP’s.

15. To ensure that quality of product is in proper order and effective IPQC is carried out by superiors.

16. To ensure that all the personnel who come to work wear proper uniforms, neatly shaven and with trimmed nails. To ensure/monitor safety of workers and other staff in departments.

17. To appraise VP-Operation / Management regarding day-to-day activities in the production department.

18. To train and arrange training for personnel. To ensure hygiene in all areas of production. To delegate responsibilities to subordinates wherever required.

19. To ensure that proper batch yields are obtained.

20. To carry out any other duties assigned by management.

21. To prepare, review and Approval of SOP’s / BMR/ BPR /Validation Protocols / Site master file / Change controls / Log books / Deviations / Quality documents etc.

22. Review and perform impact assessment of Change controls and review of closure activities of the change for disposition of change controls.

23. Review of Deviations and Incidents reports and Graphical Trends. Trending of Incidents and Deviations. Handling of Master documents. Issue and Control of documents, registers and files. Archival and destruction of documents, registers and files.

24. Allotting number for Change control forms, Request for change of formats/reference Annexures, Deviations/Incidents etc., and maintenance of the same

25. Preparation and Review of Equipment Qualification protocols (DQ/IQ/OQ/PQ) and reports. Preparation and Review of supporting system (HVAC/WFI/Purified water/Drainage) qualification protocols, monitoring the qualification studies and review of qualification reports. Preparation and Review of process validation protocols, monitoring the process validation activity, Hold time study & review of reports. Preparation and Review of Cleaning validation protocols and reports.

26. Preparation and Review of Aseptic Process simulation (Media Fill) study protocols and reports. Preparation and Review of temperature mapping studies.

27. Ensure the periodic validation of equipment’s/process simulation studies/Utilities.

28. Review of calibration data of various instruments. Review of CAPA reports for non- conformances. Review and verification of control system validation.

29. Preparation of Risk assessment protocols in compliance with current GMP guidelines.

30. Responsible for developing and implementing Quality Management System of the company.

31. Strictly ensure provisions of cGMP And Regulations are implemented / practice throughput the process of manufacturing, storage, analysis, release and distribution.

32. Devise procedures to inspect and report quality issues in the company.

33. Monitor all operation that affect quality of the products in the company.

34. Supervise and guide employees of Quality Assurance And other technical managers and executives employed in the company .

35. Assure the reliability and consistency of productivity by checking processes and final output.

36. Report all non-compliances to production executives to ensure immediate action with proper documentation.

37. Facilitate proactive solution by collecting and analyzing quality data.

38. Review current Standard And policies .

39. Keep Record of Quality reports, statistics Reviews and relevant documentation.

40. Ensure all legal standard are meet with respect to Drugs Control, Pollution control And legal Metrology.

41. You are responsible for Approve or reject, as seems fit, finished goods and other Quality Control Procedures

42. Evaluate batch records.

43. Approve Specification , sampling instruction, test methods and other Quality Control procedures.

44. Ensures that the appropriate validations are done for all machineries and equipment’s in the plant.

45. Ensure That the required initial and continuing training if all department personnel is carries out and adapted according to need.

46. Authorization of written procedures and other documents, including amendments .

47. Approval and control of suppliers ( vendors)

48. Retention of records as per statutes

49. Inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.

50. Approval of Deviation, Change control and CAPA

51. Investigation of market complaints.

Preferred candidate profile

only Candidates with Pharma experience are requested to apply.

Perks and benefits

Commensurate with experience and performance track record-will not be a constraint for the right candidates