Asst. QC Manager

Duties and responsibilities

The role would encompass a variety of responsibilities, including and not necessarily limited to the following points:

• Chemical and Instrumental Testing: Perform testing using various methods including but not limited to HPLC, FTIR, UV Spectrophotometry, Karl Fischer Titrator, Dissolution, and other chemical and instrumental techniques.
• Calibration & Equipment Maintenance: Ensure calibration and proper maintenance of all testing equipment and instruments as per regulatory standards.
• Pharmacopeia Adherence: Implement and interpret pharmacopoeial standards for testing and establishing procedures, ensuring compliance with USP, BP, IP, and other relevant pharmacopeia.
• Quality Control Documentation: Prepare and review all QC documentation as per the Drugs and Cosmetics Act, New Schedule M, WHO guidelines, and other relevant standards. This includes the preparation of AMV, specifications, SOPs, and STPs.
• Regulatory Compliance: Ensure compliance with national and international regulatory requirements such as FDCA, WHO, and MNC guidelines.
• Team Management: Lead and train a team of QC analysts and technicians, providing guidance on best practices, troubleshooting, and complex testing.
• Microbiological Testing: Oversee and manage microbiological testing, including environmental monitoring, sterility testing, endotoxin testing, and pyrogen testing.
• Analytical Method Development: Develop new analytical methods for products not listed in current pharmacopeia.
• Inspection and Audit Support: Assist in inspections by regulatory authorities (e.g., FDA, WHO, MNC, TP) and ensure that the facility meets the required quality standards.
• Reporting and Communication: Provide detailed reports on testing results, compliance audits, and other QC activities. Clearly communicate QC issues and resolutions to management and external auditors.

Key Requirements:

In order to perform your role well, the following qualities will be required:

• Educational Qualification: B.Sc., M.Sc., B. Pharm, M. Pharm, or PhD in Pharmaceutical Sciences or Chemistry.
• Certifications: FDCA approval for Chemical & Instruments.
• Experience: Minimum 15 years of experience in a pharmaceutical quality control department, with at least 5 years in a managerial capacity. Hands-on experience with all types of pharmaceutical formulations, including Tablets, Capsules, Syrups, Ointments, and Liquids.
• Testing Expertise: Proficiency in chemical (all types of titration) and instrumental methods (including but not limited to HPLC, UV, FTIR, Karl Fischer Titrator, Dissolution, GC, AAS, etc.).
• Documentation Skills: Experience in preparing and reviewing AMV, specifications, STPs, SOPs, and other regulatory documentation.
• Microbiological Testing: Basic knowledge of microbiological testing including environmental monitoring, sterility, pyrogen, and toxicity testing.
• Regulatory Compliance: In-depth knowledge of Drugs and Cosmetics Act, New Schedule M, WHO guidelines, and other regulatory standards.
• Leadership and Training: Ability to handle a team and train others in both technical and analytical skills.
• Personal Attributes: Must have a disciplined, compliant, and positive attitude. Strong character, adaptable to changing requirements, and committed to the companys growth.

Perks and Benefits:-

Duty timing : 8.30 to Lunch Time 1.00pm to 1.30pm.)

1. Personal Mobile phone not allowed inside factory premises.

2. Bed (without Bedding) in a Sharing Airconditioned accommodation is available within factory compound (Available to nondrinker / nonsmoker only)

3. Canteen facility on To pay basis available to associates living inside factory compound.

4. Non resident candidate living in near vicinity to the factory premises will be preferred.

5. Candidate willing to remain associated/stable for a minimum period of 3 year need only to apply.

Reporting time to Duty : 15 Min before the duty start time