QC Manager

Job Description

Job title Manager QC Reports to : Plant Head CTC : Salary no bar for deserving candidates Job Description: We are seeking a dedicated and skilled QC Manager for our pharmaceutical manufacturing facility. The ideal candidate will have extensive experience in chemical and instrumental testing, along with in-depth knowledge of pharmaceutical quality control standards. The role will require leadership in overseeing the quality control processes for all types of pharmaceutical products, ensuring compliance with regulatory standards, and maintaining high-quality practices within the lab environment. The QC Manager will be responsible for the testing, calibration, documentation, and preparation of various QC materials, including analytical method validation (AMV), specifications, standard operating procedures (SOPs), and Standard Testing Protocols (STP). The role also requires proficiency in microbiological testing and leadership in managing a team of professionals. 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 pharmacopoeia 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 company’s growth. Good to have skills (not mandatory): · Strong experience in handling FDA , WHO , and MNC inspections. · Ability to work extended hours as required and a flexible attitude toward work demands. · Proficient in ERP systems and familiar with computer-based testing documentation. · Ability to communicate effectively in English (both written and spoken) for internal and external communications, including audits. · Ready to live on the factory campus and demonstrate flexibility as needed. Ideal Candidate Profile: Age: Between 40-50 years . · Demonstrated leadership ability in a QC team and a proactive, solution-oriented approach to problem-solving. · Ready to take on new challenges in a dynamic, fast-paced environment, prioritizing work and the company’s growth. Candidates who wish to apply for the above position may register for interview using the below link/QR code: https://bit.ly/QCManagerMedipol Show more Show less