Qc Executive

2 weeks ago


Puducherry Puducherry, India SHASUNMED LIFE SCIENCES PVT. LTD Full time

**Job Title: QC Executive - Analytical (2 to 4 Years’ Experience)**

**Industry**: Biopharmaceutical
**Location**: Puducherry
**Department**: Quality Control - Analytical
**Reports To**: QC Manager

**Job Summary**:
We are seeking a motivated and detail-oriented **QC Analyst (Analytical)** with 2 to 4 years of experience in a regulated pharmaceutical or biopharmaceutical QC laboratory. The role involves performing analytical testing of raw materials, in-process samples, and finished products in compliance with cGMP and regulatory requirements.

**Key Responsibilities**:

- Perform routine and non-routine analytical testing of:

- Raw materials, intermediates, in-process, finished products, stability samples
- Water and cleaning validation samples (if applicable)
- Operate and calibrate analytical instruments such as:

- HPLC, GC, UV-Vis, FTIR, Karl Fischer, pH meter, Dissolution, etc.
- Prepare and review test records, logbooks, and related documentation as per GMP and data integrity standards.
- Conduct analysis as per pharmacopeial methods (USP, EP, IP, JP)
- Support in method validation/verification and equipment qualification activities.
- Review and interpret analytical results and escalate OOS/OOT results promptly.
- Maintain compliance with laboratory SOPs, GLP, and safety procedures.
- Participate in stability studies, trending data, and document control activities.
- Support investigations, deviations, and implementation of CAPAs related to QC analytical operations.
- Participate in internal and external audits and regulatory inspections.

**Qualifications**:

- M.Sc. (Chemistry, Analytical Chemistry, Biotechnology) / B.Pharm / M.Pharm
- 2 to 4 years of hands-on experience in QC Analytical in a cGMP-compliant pharmaceutical or biopharma lab

**Key Skills**:

- Handling of oncology molecules is plus
- Proficient in handling HPLC, GC, and other analytical instruments
- Familiarity with **pharmacopeial testing** (USP, EP, IP)
- Good understanding of **cGMP, GLP**, and data integrity practices
- Strong documentation and observation skills
- Working knowledge of LIMS or electronic data systems is an advantage

Pay: ₹11,407.45 - ₹27,703.75 per month

**Benefits**:

- Provident Fund

**Experience**:

- Laboratory: 3 years (required)
- Clinical laboratory: 3 years (required)
- Laboratory procedures: 3 years (required)
- Laboratory techniques: 3 years (required)

Work Location: In person



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