Torrent Pharmaceuticals, a leading pharmaceutical company in India with a global footprint, is seeking a highly motivated and experienced Cleaning Validation Executive to join its state-of-the-art Oncology Plant located in Bileshwarpura, Ahmedabad. This is an exceptional opportunity to contribute to a dynamic and rapidly growing organization within the pharmaceutical industry.
About Torrent Pharmaceuticals:
Torrent Pharmaceuticals Ltd., the flagship company of the Torrent Group, holds a prominent position among India’s top pharmaceutical companies. We are a major player in cardiovascular (CV) and central nervous system (CNS) therapeutics, and have established a significant presence in gastro-intestinal, diabetology, anti-infective, and pain management segments. Our international reach extends to over 70 countries across five continents, supported by over 1200 product registrations. With cutting-edge manufacturing and research facilities, Torrent Pharma is poised for continued growth and leadership in the global pharmaceutical arena.
Job Description: Cleaning Validation Executive (Oncology Plant)
The Cleaning Validation Executive will play a crucial role in ensuring the highest standards of cleanliness and hygiene within our Oncology Plant. This position requires a detailed understanding of current regulatory requirements and best practices in cleaning validation. Key responsibilities include, but are not limited to:
- Regulatory Compliance: Maintaining a thorough understanding of current Good Manufacturing Practices (cGMP) and relevant regulatory requirements for cleaning validation in the pharmaceutical industry. This includes staying up-to-date on evolving regulations and implementing necessary changes to our processes.
- Validation Documentation: Developing and executing comprehensive cleaning validation protocols and reports. This involves meticulous documentation of all procedures, results, and deviations. Preparation of the cleaning validation master plan is also a key responsibility.
- Matrix Development and Worst-Case Scenario Identification: Creating and implementing cleaning validation matrices using approaches such as Maximum Allowable Carryover (MACO) and solubility studies to identify worst-case scenarios and ensure effective cleaning procedures. Accurate surface area calculations will be required for thorough validation.
- Sampling and Inspection: Proficiently performing swab and rinse sampling techniques. Conducting visual inspections of direct and indirect contact parts to ensure cleanliness and adherence to established standards. Experience with DEHT/CEHT and campaign cleaning is highly desirable.
- Data Analysis and Reporting: Analyzing validation data, interpreting results, and generating comprehensive reports that clearly communicate findings and conclusions to relevant stakeholders. This includes identifying trends and suggesting improvements to cleaning procedures as necessary.
Qualifications and Experience:
- Master of Science (MSc), Bachelor of Science (BSc), Master of Pharmacy (MPharm), or Bachelor of Pharmacy (BPharm) degree.
- 1 to 6 years of experience in cleaning validation within a pharmaceutical manufacturing environment. Experience in an oncology setting is preferred but not mandatory.
- Strong knowledge of cGMP and regulatory requirements related to cleaning validation.
- Proven ability to develop, execute, and document cleaning validation protocols and reports.
- Proficiency in data analysis and interpretation.
- Excellent organizational, communication, and problem-solving skills.
- Ability to work independently and as part of a team.
Key Skills:
- Cleaning Validation
- cGMP
- Regulatory Compliance
- Data Analysis
- Swab Sampling
- Rinse Sampling
- DEHT/CEHT
- MACO Analysis
- Solubility Studies
- Documentation
How to Apply:
Interested and qualified candidates are invited to submit their application by emailing the following to oncologyplant@torrentpharma.com:
- An updated resume highlighting relevant experience and skills.
- Your availability for an online interview (Monday to Saturday, 10:00 am to 05:00 pm).
Location:
Vil. Bileshwarpura, Ahmedabad – Mehsana Highway, Ta. Kalol, Dist. Gandhinagar – 382729, Gujarat, India.
We offer a competitive salary and benefits package in a dynamic and rewarding work environment. If you are a highly motivated individual with a passion for pharmaceutical manufacturing and a commitment to quality, we encourage you to apply. Torrent Pharmaceuticals is an equal opportunity employer.
