Qc Chemist

6 days ago

Sachin Surat Gujarat, India Trident Full time

**Job description:

- **

**Instrumental Analysis**:

- Perform routine and stability analysis of raw materials, intermediates, and finished products using **HPLC, UV-Vis Spectrophotometer, FTIR**, etc.
- Operate and calibrate analytical instruments as per SOPs and regulatory guidelines.
- Troubleshoot HPLC and other lab equipment in coordination with service engineers when required.

**Documentation & Compliance**:

- Prepare and maintain **analytical reports, test data sheets, protocols, and logs** as per GDP (Good Documentation Practices).
- Ensure all QC activities comply with **cGMP, GLP, and other regulatory guidelines**.
- Assist in investigation and documentation of **OOS, OOT, and deviations**.
- **Sample Handling & Testing**:

- Receive and analyze **raw material, packaging material, in-process samples, and finished goods** as per approved specifications.
- Maintain proper sample disposal records.
- **SOP & Record Management**:

- Review and update **Standard Operating Procedures** (SOPs), specifications, and analytical methods.
- Maintain laboratory notebooks, logbooks, equipment usage logs, and calibration records accurately.
- **Equipment Handling & Calibration**:

- Operate and maintain lab instruments including **HPLC, Dissolution Test Apparatus, pH meter, Analytical Balance, etc.**:

- Conduct periodic calibration and qualification of instruments.
- **Audit Readiness**:

- Prepare and support **internal and external audits** (e.g., USFDA, WHO, MHRA).
- Maintain complete and audit-ready documentation at all times.

**Key Skills & Competencies**:

- Hands-on experience in **HPLC analysis and troubleshooting**.
- Strong understanding of **analytical chemistry, GMP, GLP**, and **ICH guidelines**.
- Attention to detail, data integrity, and documentation accuracy.
- Good communication and team coordination skills.
- Proficiency in **MS Office** and LIMS (preferred).

**Qualifications**:

- **B.Pharm / M.Pharm / M.Sc / B.Sc (Chemistry or related field)**:

- Minimum **2-5 years** of experience in QC in a **regulated pharmaceutical environment**.

**Additional Requirements**:

- Willingness to work in shifts (if applicable).
- Sound knowledge of **safety protocols and laboratory hygiene**.
- Good analytical and problem-solving abilities.
- Familiarity with **regulatory audits and compliance standards**.

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

Pay: ₹18,000.00 - ₹25,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance
- Paid sick time
- Provident Fund

Work Location: In person

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