Quality Control - Pharma Formulation

Required - Quality Control Analyst

Location: Ankleshwar, Gujarat, India

Industry- Pharma Formulation

Must have 3-5 Years of Experience (Must be from Formulation Industry)

Job Description:

As a Quality Control Analyst in pharmaceutical manufacturing, you will play a vital role in ensuring the quality, purity, and safety of raw materials, intermediate products, and finished pharmaceutical products. Your primary responsibility will be to perform analytical testing and quality assessments according to established procedures and regulatory requirements.

Key Responsibilities:

Analytical Testing: Perform a variety of analytical tests on raw materials, in-process samples, and finished products using laboratory equipment such as HPLC, GC, UV-Vis spectrophotometer, dissolution apparatus, and other instruments. Conduct tests to assess chemical composition, physical properties, and microbiological attributes.

Method Development and Validation: Develop and validate analytical test methods for the analysis of pharmaceutical products, in accordance with regulatory guidelines and industry standards. Optimize methods for accuracy, precision, sensitivity, and specificity, and ensure compliance with validation requirements.

Sample Preparation: Prepare samples for analysis by following established procedures for sample collection, extraction, dilution, and filtration. Ensure proper handling and storage of samples to prevent contamination, degradation, or loss of integrity.

Data Analysis and Interpretation: Analyze test results and interpret data to assess product quality, compliance with specifications, and adherence to regulatory requirements. Identify deviations, out-of-specification (OOS) results, and trends, and communicate findings to relevant stakeholders.

Instrument Calibration and Maintenance: Perform routine calibration, maintenance, and troubleshooting of laboratory equipment to ensure accuracy, reliability, and compliance with regulatory requirements. Document instrument performance and maintenance activities according to established procedures.

Documentation and Recordkeeping: Maintain accurate and up-to-date records of analytical testing activities, including test results, laboratory notebooks, instrument logbooks, and electronic data records. Ensure that all documentation is complete, legible, and traceable for review and audit purposes.

Compliance Oversight: Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines, and company policies and procedures. Participate in internal and external audits, inspections, and quality assessments, and implement corrective actions as needed.

Quality Control Review: Review and approve analytical test data, laboratory reports, and quality control records generated by other analysts or technicians. Verify the accuracy and completeness of data and documentation before release for further processing or product release.

Continuous Improvement: Identify opportunities for process improvement, efficiency gains, and cost savings within the quality control laboratory. Participate in quality improvement initiatives, root cause investigations, and CAPA implementation to enhance overall laboratory performance.

Qualifications:

Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.

Previous experience in a pharmaceutical quality control laboratory, preferably in a cGMP-regulated environment.

Proficiency in analytical techniques and instrumentation, including HPLC, GC, UV-Vis spectrophotometry, and dissolution testing.

Strong understanding of cGMP regulations, regulatory guidelines (e.g., FDA, ICH), and quality management systems.

Excellent attention to detail, organization, and time management skills.

Strong problem-solving and troubleshooting abilities.

Effective communication and interpersonal skills, with the ability to work collaboratively in a team environment.

Proficiency in MS Office applications and laboratory information management systems (LIMS).