Executive - QA (FORM)

Torrent Pharmaceuticals; Dahej; On-site; INR 350,000 - 520,000; Full time

Job summary

Torrent Pharmaceuticals in Dahej, Gujarat, seeks an Executive with B. Pharm. / M. Pharm. to join QA/Validation. The role emphasizes cleaning validation, regulatory compliance, and robust documentation.

The incumbent will lead SOPs, change controls, risk assessments, and site/master file preparation while supporting audits and training within a cGMP framework. OSD formulation experience is mandatory and on-site work is expected.

Qualifications

• Regulatory and quality assurance experience.
• Knowledge of cGMP and GDP principles.
• Experience with SOPs and validation activities.
• OSD Formulation exposure is mandatory.

Responsibilities

• Ensure compliance of regulatory and customer requirements.
• Update and implement current regulatory guidelines for awareness across relevant personnel.
• Execute and review cleaning validation/verification protocols and reports.
• Review new product and equipment introductions for cleaning validation; establish worst-case product per SOP.
• Update cleaning validation documents: equipment/product matrices, rationale, master plan, sampling and surface area calculations.
• Report discrepancies observed during cleaning validation to QA head.
• Sample cleaning validation materials.
• Investigate deviations/Out of Specification related to cleaning validation.
• Review and evaluate change controls for facility, equipment, processes, controls, utilities, and starting materials.
• Involve in risk assessment and review of risks to drug quality across lifecycle.
• Prepare and review Site Master File and Validation Master Plan.
• Support audit handling and compliance.
• Prepare and review QA SOPs and training documentation.
• Handle document control: issuance, retrieval, archival, storage, destruction.
• Provide training on cGMP, GDP, SOPs and related topics.
• Follow Quality, Health, Safety & Environmental policies.
• Accept additional responsibilities from seniors/QA Head as needed.

Skills

Quality Assurance

Regulatory Compliance

cGMP

GDP

SOPs

Audits

Education

B. Pharm. / M. Pharm.

Job description

Roles & Responsibilities:

1. To ensure the compliance of the regulatory and customer requirements.
2. To update myself and implement with the current regulatory guidelines and legal compliance for making it aware to relevant person.
3. Execution and review of validation/verification protocols and reports for cleaning validation/verification study.
4. To review the assessment and evaluation of new product and new equipment introduction for cleaning validation and verification requirement and establish the worst case product as per SOP and current regulatory guidelines as per available Product matrix.
5. To update cleaning validation documents like equipment matrix, product matrix, scientific rationale, attachment IV, attachment V, Validation master plan, sampling manual and Surface area calculation etc.
6. Reporting and addressing of any discrepancies observed during Cleaning Validation activity to report critical and major observation to QA head.
7. Sampling of cleaning validation samples.
8. To investigate any Deviation, Out of Specification related failure in cleaning Validation.
9. To review and evaluate the change control for facility, equipment, processes, control parameters, utilities, key starting materials, procedures and specifications as per respective SOP.
10. To involve in the activity for the risk assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle, systems, utilities, facility and other associated aspects.
11. To prepare & review of Site Master File.
12. To prepare & review of Validation Master Plan.
13. To support audit handling and compliance.
14. To prepare & review of SOPs of QA department.
15. Review and verification of training related documentation activities.
16. Handling of documentation control activities like issuance, retrieval, archival, storage and destruction.
17. To impart training related to cGMP, GDP, SOPs, but not limited to.
18. To follow the procedure related with Quality, Health, Safety, & Environmental policy.
19. Any additional responsibility assigned by superiors and QA Head on the basis of qualification and experience.

Qualification:

B. Pharm. / M. Pharm.

Designation:

Executive

Location:

Dahej, Gujarat

Note:

OSD Formulation experience mandatory.