QA Executive

2 days ago

Thaltej Ahmedabad Gujarat, India Smartway wellness pvt ltd Full time

**Job Summary**:
**Key Responsibilities**:

- Coordinate with third-party manufacturing (TPM) and packaging sites to ensure adherence to company and regulatory quality standards.
- Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs) from TPMs.
- Monitor and support investigation of deviations, change controls, and CAPAs for timely resolution.
- Conduct periodic quality audits and site visits; prepare audit reports and follow up on observations.
- Review and approve quality documentation (SOPs, protocols, reports) submitted by TPMs.
- Ensure timely QA product release by coordinating with site QA teams and internal departments.
- Maintain and update Quality Agreements with third-party manufacturing partners.
- Support customer audits and regulatory inspections (WHO, MHRA, USFDA, etc.) at TPM sites.
- Track and report key quality metrics to management related to third-party operations.
- Provide training and support to QA/QC teams at third-party sites when required.
- Collaborate with internal teams including Regulatory Affairs, Production, R&D, and Supply Chain for smooth operations.
- Manage new product registration processes and associated documentation.
- Oversee brand registration on Trade Safe platform.
- Handle NPPA/DPCO-related compliance and submissions.
- Coordinate with labs for sample testing activities and ensure timely Certificate of Analysis (COA) issuance.

**Qualifications**:

- B.Pharm / M.Pharm / M.Sc. in Life Sciences.
- 2-5 years of QA experience in the pharmaceutical industry, preferably in a corporate QA or third-party manufacturing role.
- Sound knowledge of cGMP, ICH guidelines, and Indian regulatory frameworks.
- Hands-on experience in batch record review, documentation control, and vendor compliance.
- Familiarity with NPPA/DPCO requirements and regulatory processes.

**Desired Skills**:

- Experience working with multiple third-party manufacturers and packagers.
- Strong communication and coordination skills across cross-functional and external teams.
- Proficiency in MS Office and quality documentation tools.
- Willingness to travel to TPM sites for audits, training, or compliance support.

**Job Types**: Full-time, Permanent

Pay: Up to ₹40,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Work Location: In person

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