Executive - QA

Intertek; Mumbai; On-site; INR 600,000 - 850,000; Full time

Job summary

Intertek is seeking a Quality Assurance/QA Compliance professional in Mumbai to oversee cGMP-aligned laboratory documentation, data review, and QMS maintenance. The role requires ensuring SOP adherence, archival integrity, and timely audit preparation across the quality management system, with responsibilities spanning training, incident investigations, and CAPA implementation.

The candidate will conduct daily rounds to verify cGLP compliance, coordinate cross-functionally for continual QMS

Responsibilities

• Review of the laboratory documentation and activity in-line with cGMP requirements.
• Review of raw data, protocols, reports and all other documents as per cGMP requirement.
• Ensure that process needed for the Quality management system are established, implemented and maintained within the laboratory.
• Issuance of all formats, protocols and raw data sheets upon request.
• Maintaining log and records of all issuances, distribution, destruction and archival in line with SOP.
• Archival of documents, reports, raw data and maintaining log of the same inline with SOP. Monitoring and recording temperature and humidity of archival area as per SOP.
• Preparation and review of standard operating procedure.
• Preparation of audit compliance report and keeping track to meet the target dates.
• Report to immediate reporting person/Head QA/superior on the performance of the Quality Management system and may need for improvement.
• Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for Identification, storage, protection, retrieval, retention and destruction of such records.
• Providing the training to all new staff for effective implementation of QMS as applicable.
• Ensure that an internal audit program is adopted to verify that the QMS confirmed to planned arrangement.
• Conducting daily laboratory round to ensure compliance to current cGLP requirements.
• Co-ordinate with team and cross functional team for continual improvement of QMS, Ensuring that evidence of corrective and preventive action taken are recorded and reviewed.
• Supporting to operation team in incident investigation, OOS investigation and deviation investigation and keeping track of the same for timely closure.
• Providing the required support and making arrangement of documents during external audit.
• Responding to customer complaints, support in investigation and CAPA implementation.
• Maintaining training records of all the employees, circulating information about upcoming training to all employees.

Job description

Roles & Responsibilities

1) Review of the laboratory documentation and activity in-line with cGMP requirements.

2) Review of raw data, protocols, reports and all other documents as per cGMP requirement.

3) Ensure that process needed for the Quality management system are established, implemented and maintained within the laboratory.

4) Issuance of all formats, protocols and raw data sheets upon request.

5) Maintaining log and records of all issuances, distribution, destruction and archival in line with SOP.

6) Archival of documents, reports, raw data and maintaining log of the same inline with SOP. Monitoring and recording temperature and humidity of archival area as per SOP.

7) Preparation and review of standard operating procedure.

8) Preparation of audit compliance report and keeping track to meet the target dates.

9) Report to immediate reporting person/Head QA/superior on the performance of the Quality Management system and may need for improvement.

10) Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for Identification, storage, protection, retrieval, retention and destruction of such records.

11) Providing the training to all new staff for effective implementation of QMS as applicable.

12) Ensure that an internal audit program is adopted to verify that the QMS confirmed to planned arrangement.

13) Conducting daily laboratory round to ensure compliance to current cGLP requirements.

14) Co-ordinate with team and cross functional team for continual improvement of QMS, Ensuring that evidence of corrective and preventive action taken are recorded and reviewed.

15) Supporting to operation team in incident investigation, OOS investigation and deviation investigation and keeping track of the same for timely closure.

16) Providing the required support and making arrangement of documents during external audit.

17) Responding to customer complaints, support in investigation and CAPA implementation.

18) Maintaining training records of all the employees, circulating information about upcoming training to all employees.