Executive - Quality Control

5 days ago

Navi Mumbai Maharashtra, India Piramal Pharma Solutions Full time

**Job Overview**

To perform quality control testing of raw materials, intermediates, and finished products as per approved specifications, ensuring compliance with cGMP, regulatory, and company standards.

**Roles and Responsibilities**:

- Conduct chemical and instrumental analysis of raw materials, intermediates, and peptide APIs using HPLC, GC, UV-Vis, IR, Karl Fischer, and TOC.
- Execute peptide-specific analytical techniques including reverse-phase and ion-exchange HPLC, amino acid analysis, and peptide mapping where applicable.
- Perform method validation, verification, and transfer in line with ICH guidelines.
- Maintain and review analytical documentation such as SOPs, STPs, specifications, and validation protocols.
- Ensure compliance with cGMP, GLP, and data integrity practices in all laboratory operations.
- Support OOS/OOT investigations, perform root cause analysis, and assist in CAPA implementation.
- Monitor calibration, maintenance, and qualification of analytical instruments as per the approved schedule.
- Prepare samples and documents for regulatory submissions and audits (e.g., DMF support, ANDA filings).
- Coordinate with QA, RA, Production, and R&D for timely resolution of issues and release of batches.
- Participate actively in regulatory audits (USFDA, EUGMP, WHO, etc.) and internal quality audits.

**Experience**

1-4 years of experience in QC in pharmaceutical / chemical / API manufacturing industry

**Competencies**
- Hands-on experience with instruments like HPLC, GC, UV-Vis, and others.
- Sound understanding of cGMP, GLP, and regulatory guidelines
- Strong documentation and communication skills.
- Ability to work in shifts and under pressure.
- Team player with problem-solving and analytical skills.

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