Executive - QC

Job Title:

Company:

Our GMP compliant, State of Art manufacturing facility for Tablet, Oral Dry Powder, Capsule, Nasal sprays, DPIs, Cream, Gel and Ointment formulations with dedicated manufacturing sections supported by In-House RD Center, focuses on Formulation and Analytical Development with an annual turnover of more than 200 crores and manpower of 500+ employees engaged across locations.

Job Location:

Job Overview:

The Executive Quality Control (QC) will play a crucial role in ensuring the quality and compliance of pharmaceutical products manufactured at our facility. This position involves conducting various tests, analyses, and inspections to ensure products meet regulatory standards and internal quality benchmarks. The Executive QC will also support continuous improvement initiatives within the QC department.

Key Responsibilities:

1. Quality Testing and Analysis:
2. Conduct routine and non-routine chemical, physical, and microbiological testing of raw materials, in-process samples, and finished products.
3. Perform stability testing and validation studies as required.
4. Utilize advanced analytical instruments such as HPLC, GC, UV-VIS spectrophotometers, and others.
5. Documentation and Compliance:
6. Maintain accurate and detailed records of all testing and inspections performed.
7. Ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and other relevant regulatory standards.
8. Prepare and review Standard Operating Procedures (SOPs) and test methods.
9. Inspection and Audits:
10. Conduct internal audits and participate in external audits to ensure compliance with quality standards.
11. Inspect incoming raw materials and packaging materials to verify conformance to specifications.
12. Investigate and resolve quality issues, including out-of-specification results and deviations.
13. Continuous Improvement:
14. Identify areas for improvement within the QC processes and suggest enhancements.
15. Participate in root cause analysis and implement corrective and preventive actions (CAPA).
16. Training and Development:
17. Train and mentor junior QC staff on testing procedures, equipment use, and regulatory requirements.
18. Stay updated with the latest advancements in QC techniques and industry trends.
19. Cross-Functional Collaboration:
20. Collaborate with production, RD, regulatory affairs, and other departments to ensure seamless quality control processes.
21. Support new product development by providing QC expertise and conducting necessary tests.

Qualifications:

• Bachelors or Master s degree in Chemistry, Pharmacy, Microbiology, or a related field.
• Minimum of 3-5 years of experience in Quality Control within the pharmaceutical industry.
• Proficiency in using analytical instruments and software (e.g., LIMS).
• Strong understanding of GMP, GLP, and other regulatory requirements (e.g., FDA, EMA).
• Excellent attention to detail and strong analytical skills.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.

Preferred Qualifications:

• Experience with advanced analytical techniques and method development.
• Certification in Quality Management Systems (e.g., ISO 9001).
• Knowledge of current industry trends and best practices.

Physical Requirements:

• Ability to work in a laboratory setting with exposure to chemicals and pharmaceutical compounds.
• Ability to lift and move equipment and materials as necessary.

Working Conditions:

• Primarily a laboratory environment, with some exposure to manufacturing areas.
• Occasional travel may be required for training and audits.