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
• Bachelor’s 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