Quality Assurance

2 months ago


Mumbai, India Yo Hr Consultancy Full time

**Sr Executive
- CQA**

**Location
- Mumbai**

**Experience
- 7 to 9 years**

**Must have-**

**Experience in CQA and CSV**

Key Responsibility Areas

**Regulatory & Compliance**:

- Computerized System’s Lifecycle Management - Shall responsible to assess and initiate change control based on observation during qualification or routine observation for GxP impacting computerized systems. - Shall identify and document the observed or occurred deviations for GxP impacting computerized systems. - Shall thoroughly evaluate the root cause and causes assigned for proposed CAPA for GxP impacting computerized systems.

**Validation Strategies**:

- To prepare the project plan and initiate subsequent actions w.r.t. GxP computerized systems validation activities. - Shall responsible for preparation and review of validation/ qualification document related to GxP impacting computerized systems as per the 21CFR part 11& EU Annex 11 & GAMP 5 requirements. - Ensure the necessary validation documentation is completed in alignment with the CSV SOP and policies before release of the GxP computerized systems to users. - Shall be responsible for coordination with vendor for implementation of task and it's documentation for end to end validation of GxP impacting computerized systems.

**Management Information Systems (MIS) And Analytics**:

- Update the project trackers of CSV activity on real time basis. - Weekly review of the CSV activity with the team lead. - Prepare monthly report of all activities and submit to team lead for review.

**Audits**:

- Shall prepare for regulatory audits conducted by In-house, Customer and Regulatory Agencies, which require computer system validation.

**Learning & Improvement**:

- Nominate self for and attend relevant internal/external trainings - Take initiatives for selfdevelopment and update self on recent developments in own area of work. - Review processes in own area of work and recommend improvements. - Assist in induction training of newjoiners (based on expertise/ experience)

**Salary**: ₹700,000.00 - ₹1,000,000.00 per year

Schedule:

- Flexible shift

**Experience**:

- CQA: 3 years (preferred)
- CSV: 3 years (preferred)

**Speak with the employer**
+91 7999182779


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