Regulatory Affairs

Urgent Requirement - Executive/AM Regulatory Affairs

Experience - Min 3 to 5 years

Qualification - Minimum Graduate/Post Graduate

Industry - Pharma/Homeopathy

Sal. - 25k - 30k per month
- Responsible for implementation of Quality Management System as per regulatory requirements.
- Responsible for product approval from drug authority.
- Regulatory Documentation.
- Management of the Continual Improvement of the Systems, Product Quality Review Process for the Corrective and Preventive Action System.
- Accountable for the Data integrity and implementation of the SOP and policy.
- Evaluate & approval of master documents pertaining to various departments.
- Responsible for preparation and approval of all master documents like BMR, SOP, STP, SPEC, formats and checklist.
- Accountable for Control Sample Management and Stability Management.
- Responsible for implementation of QA systems for ensuring that compliance as per sops.
- Handling of market complaints.
- Responsible for external & internal audits.
- Responsible for cGMP related Training.
- Ensuring timely evaluation, approval, and closure of incidence, deviations, CAPA and change controls.
- Review, evaluation, and approval of Document on behalf of factory department in guidance of technical head.
- To follow cGMP practices and implementation of the information recorded.
- Responsible for review and approval of equipment qualification/ requalification/ validation protocols, a compilation of summary reports of the products.
- Follow-up with purchase, and export department for various for various materials and order.

**Salary**: ₹20,000.00 - ₹30,000.00 per month

**Benefits**:

- Cell phone reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Bhiwadi, Alwar - 301018, Rajasthan: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 2 years (preferred)

Work Location: One location