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Quality Control Hplc Operator

3 weeks ago

Panchkula, India Vibcare Pharma Pvt Ltd Full time

Quality Control (QC) Analyst - High-Performance Liquid Chromatography (HPLC) in Pharma Manufacturing

Position Overview:
As a Quality Control Analyst specializing in High-Performance Liquid Chromatography (HPLC) within the pharmaceutical manufacturing sector, you will be responsible for performing analytical testing using HPLC techniques to ensure the quality and integrity of pharmaceutical products. Your role will involve conducting method validation, sample analysis, and data interpretation to support manufacturing operations and regulatory compliance.

Key Responsibilities:

- HPLC Analysis:

- Perform routine and non-routine analysis of raw materials, in-process samples, and finished products using HPLC instrumentation.
- Develop, optimize, and validate HPLC methods for the analysis of various pharmaceutical compounds in accordance with regulatory requirements.
- Conduct sample preparation, chromatographic separation, and detection of target analytes following established procedures and protocols.
- Method Validation:

- Design and execute method validation studies for HPLC methods to demonstrate accuracy, precision, specificity, and robustness.
- Generate validation protocols, execute validation experiments, and analyze validation data to ensure compliance with regulatory guidelines (e.g., ICH, FDA).
- Document validation results and prepare validation reports for review and approval by regulatory authorities.
- Instrument Maintenance:

- Perform routine maintenance, calibration, and troubleshooting of HPLC instruments to ensure optimal performance and reliability.
- Monitor instrument performance parameters such as column efficiency, detector sensitivity, and system suitability to maintain data integrity.
- Coordinate with instrument vendors or service providers for instrument repairs and upgrades as needed.
- Data Analysis and Reporting:

- Analyze HPLC data using appropriate software tools to interpret chromatograms, calculate analyte concentrations, and assess sample quality.
- Review and approve analytical data generated from HPLC analyses, ensuring accuracy, completeness, and compliance with standard operating procedures (SOPs).
- Prepare analytical reports summarizing test results, deviations, and any out-of-specification findings for review by QC management and regulatory authorities.
- Compliance and Documentation:

- Ensure adherence to Good Manufacturing Practices (GMP) and regulatory guidelines in all QC activities related to HPLC analysis.
- Maintain accurate and up-to-date documentation of all analytical procedures, test results, instrument logs, and related records in compliance with SOPs and regulatory requirements.
- Participate in internal and external audits of the QC laboratory, providing documentation and support as needed to demonstrate compliance with quality standards.
- Continuous Improvement:

- Identify opportunities for process optimization and efficiency improvements in HPLC analysis workflows.
- Collaborate with cross-functional teams to implement quality improvement initiatives, address root causes of deviations, and prevent recurrence of quality issues.
- Stay informed about advances in HPLC technology, regulatory requirements, and industry best practices to enhance analytical capabilities and ensure continuous improvement.

Qualifications:

- Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or a related field.
- **Minimum of 2 years of experience** in pharmaceutical quality control, with specific expertise in HPLC analysis.
- Strong knowledge of HPLC principles, instrumentation, method development, and validation.
- Familiarity with regulatory requirements and guidelines (e.g., FDA, ICH) related to analytical method validation and pharmaceutical quality control.
- Proficiency in using HPLC software for data analysis and interpretation.
- Excellent attention to detail, organizational skills, and ability to work effectively in a team environment.
- Strong communication skills, both verbal and written.

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

**Salary**: ₹10,378.08 - ₹30,502.13 per month

**Benefits**:

- Health insurance
- Life insurance
- Paid sick time

Schedule:

- Day shift

**Experience**:

- HPLC operator total work: 2 years (required)

Ability to Commute:

- Panchkula, Haryana (required)

Ability to Relocate:

- Panchkula, Haryana: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**

+91 7888979205