Quality Control Chemist

Job Description for QC role (with 10 to 12 years of experience)

Candidate should be B. Sc/M. Sc/B. Pharm/M. Pharm with 10 to 12 years of experience in handling APIs and excipients.

Candidate should have adequate knowledge of wet analysis, titrations and handling of instruments like Gas Chromatography, UV Spectrophotometer, Flame Photometer, RI, pH meter, HPLC etc.

Should have good communication skills. (Written and Verbal)

Should have knowledge of QA related activities. Should be well versed with Change Control, Investigations, Deviations, CAPA, Documentation, Audit handling etc.

Should have basic leadership skills to guide a team of 3 or more associates.

Should be a team player.

Should have basic knowledge of Word, Excel, Powerpoint.

Should have knowledge of regulatory compliance, Stability requirements, Validation requirements, Safety requirements, Instrument installation, Calibration, Preventive Maintenance, Preparation of SOPs and other documents.

Should be able to coordinate with internal and external stakeholders.

Candidate is expected to handle activity at multiple locations and be ready to travel to different location, if required.

Preferably have interest and capability for analytical method development for new samples.

Responsible for

Handling and guiding the team of associates to ensure complete GMP and GLP compliance.

Planning for analytical activity and ensuring timely release of materials and achieving deliverables.

Review of analytical raw data, SOPs, BMRs, COAs.

Reconciliation and Issuance (as applicable) of documents.

Retrieval and archival of documents.

Providing inputs for Change controls and all Quality events. E.g. OOS, OOT, Laboratory incident, Deviations etc.

Ensuring all documents are generated as per ALCOA+ principals.

Trending of data.

Following laid down safety requirements.

Performing any other task assigned by their supervisor.cross-functional teams to address quality issues.

Qualifications

• Proficiency in Quality Control processes and techniques to ensure compliance with established standards
• Strong Laboratory Skills, including sample testing, solution preparation, and accurate data documentation
• Advanced Analytical Skills for identifying, analyzing, and resolving quality-related issues
• Experience in utilizing and maintaining Laboratory Equipment and ensuring proper Calibration procedures
• Bachelors degree in Chemistry, Biochemistry, or a related field
• Familiarity with cGMP regulations and quality management systems is highly desirable
• Detail-oriented approach with excellent problem-solving and organizational skills
• Strong communication and teamwork abilities

Location : BHIWANDI