Ra / QA - Executive (Api - Pharmaceuticals

5 days ago

Mumbai, India Modern group PVT LTD Full time

**Job description**
- To prepare documents for local regulatory submission.
- To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING.
- To prepare Standard Operating Procedures for all departments. To perform product quality review. Follow quality assurance systems as per cGMP guidelines.
- To follow system for releasing or rejecting of all APIs. To perform validation, calibration, qualification and line clearance.
- To prepare product labels and establishing a system to control issuance of labels.
- To ensure that all manufacturing operations, documentation & records comply with ICH Q7 system. To provide document to support vendor questionnaire received from customers.
- To perform and support all RA and QA related activities.
- To prepare/compile documents for preparation of open/applicant part DMF and to provide it to customers of various region. To provide information/data/documents for any query related to open part DMF.
- Submission of DMF to regulstory agency/agent. To collect data and documents for to prepare DMF in eCTD format and to prepare DMF for various region as per region specific guideline.
- To prepare and submit annual updates in due time.
- To track updation in various regulatory guidelines and pharmacopoeial monographs..
- Extensive experience in the pharmaceutical industry with a strong understanding of drug regulatory requirements and processes.

**Role**:Regulatory Affairs Compliance

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

**Benefits**:

- Flexible schedule
- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (required)

Ability to Commute:

- Mumbai, Maharashtra (required)

Ability to Relocate:

- Mumbai, Maharashtra: Relocate before starting work (required)

**Speak with the employer**
+91 9509628515

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