QA / QC : Officer - Executive

Job Description

Role & responsibilities

Quality Control

1. Attending regulatory and customer audits.

2. Preparation and implementation of SOPs as per regulatory requirements.

3. Evaluating training needs of teams & conducting GMP, GLP & other training programs for employees across levels & functions.

4. Conducting basic GMP, refreshing/updating GMP training to all company employees.

5. Supervising the quality audit process for RM & PM vendors, contract manufacturing sites & third-party sites.

6. Preparing sample management system for control, validation, stability & market/customer samples

7. Overseeing dossier preparation and filing, planning, preparation, review, and evaluation of related documents

Quality Assurance

1. To prepare Annual Product Quality Report.
2. Review and handling of Change control.
3. Handling of Training related software (CAMS) and execution.
4. To involve in validation of Training manager software (CAMS)
5. Preparation of Quality Assurance SOPs.
6. Review of executed batch manufacturing and batch packing record and analytical
7. protocol.
8. To prepare product process validation protocol and report.
9. Overall handling and leader of document cell department.
10. To prepare Quality Management Review meeting report.
11. To fill Vendor questionnaires

Preferred candidate profile

1. Must have experience in API Industries

2. Must have knowledge of HPLC, GC system

Perks and benefits

Bus & Canteen Facility Available

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