Qc Chemist, Hplc

Posit**ion Title**: QC Chemist (GLP)

**Department**: Quality Control

**Location**: [Insert Location]

**Reports to**: QC Manager / Senior QC Chemist

**Job Purpose**:
The QC Chemist (GLP) is responsible for ensuring the quality and safety of pharmaceutical products through rigorous testing, analysis, and compliance with Good Laboratory Practices (GLP) in a pharmaceutical manufacturing environment. The role ensures that all products meet internal quality standards and regulatory requirements before reaching the market.

**Key Responsibilities**:

- **Analytical Testing**:

- Perform chemical, physical, and microbiological testing of raw materials, in-process samples, finished products, and stability studies.
- Conduct instrument-based testing using techniques such as HPLC, GC, FTIR, UV-Vis, and others.
- Ensure all tests are conducted according to approved SOPs and testing protocols.
- **Compliance with GLP and Regulatory Guidelines**:

- Maintain compliance with GLP, GMP (Good Manufacturing Practices), and other applicable regulatory standards (FDA, EMA, ICH).
- Ensure proper documentation and record-keeping of all testing results.
- Conduct regular reviews and audits of laboratory practices to ensure GLP compliance.
- Report and investigate deviations or non-conformance, and implement corrective actions.
- **Laboratory Equipment Maintenance**:

- Ensure calibration and maintenance of laboratory instruments and equipment.
- Troubleshoot and repair minor equipment malfunctions.
- Coordinate with the maintenance department for major repairs or upgrades.
- **Documentation & Reporting**:

- Prepare and maintain accurate records of all testing results, including raw data, analysis reports, and certificates of analysis (COA).
- Write and review test protocols, methods, and reports to ensure compliance and accuracy.
- Ensure data integrity, confidentiality, and proper storage of all records.
- **Sample Management**:

- Receive, label, and track raw material and product samples.
- Ensure that samples are retained as per regulatory guidelines.
- **Training and SOP Adherence**:

- Participate in training sessions on GLP, GMP, and any new testing methodologies.
- Ensure adherence to SOPs and GLP guidelines for all laboratory activities.
- Assist in the preparation and review of new SOPs and methods.
- **Collaboration & Communication**:

- Work closely with other departments such as production, R&D, and regulatory affairs to ensure smooth workflow and address quality concerns.
- Communicate results and quality issues to senior management.

**Key Requirements**:

- **Education**: Bachelor’s/Master’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
- **Experience**: 2+ years of experience in a pharmaceutical Quality Control (QC) laboratory, with a focus on GLP, preferably in a manufacturing environment.
- **Technical Skills**:

- Proficiency in analytical instrumentation (e.g., HPLC, GC, UV, FTIR, etc.).
- Knowledge of GLP, GMP, and other relevant regulatory requirements.
- Familiarity with software for data analysis and reporting (e.g., LIMS, MS Office).
- **Attention to Detail**: High degree of accuracy and attention to detail in analytical testing and documentation.
- **Communication Skills**: Strong verbal and written communication skills.
- **Problem-Solving**: Ability to identify problems and implement effective corrective actions.
- **Teamwork**: Ability to work collaboratively in a cross-functional team environment.

**Desired Qualifications**:

- Certification in GLP or relevant quality control/assurance training.
- Knowledge of pharmaceutical manufacturing processes.
- Experience with stability studies and handling regulatory submissions.

**Physical Requirements**:

- Ability to stand for long periods.
- Ability to lift and carry lab equipment and samples.
- Comfortable working in a laboratory environment with chemicals and reagents.

**Note**: The above job description outlines the main responsibilities and qualifications for the role of QC Chemist (GLP) in a pharmaceutical manufacturing unit. Additional duties may be assigned as per business needs.

You said:Job discription for QC CHEMIST HPLC in pharmaceutical manufacturing unit ChatGPT said:ChatGPT

**Job Description: QC Chemist (HPLC) - Pharmaceutical Manufacturing Unit**

**Position Title**: QC Chemist (HPLC)

**Department**: Quality Control

**Location**: [Insert Location]

**Reports to**: QC Manager / Senior QC Chemist

**Job Purpose**:
The QC Chemist (HPLC) is responsible for performing high-performance liquid chromatography (HPLC) testing in the Quality Control department of a pharmaceutical manufacturing unit. This role ensures the accurate and reliable testing of raw materials, in-process materials, and finished products to meet established quality standards and regulatory requirements. The QC Chemist (HPLC) ensures that all analytical results are documented and compliant with Good Manufacturing Practices (GMP).

**Key Responsibi