QCM

This role involves managing and directing the Quality Control and Microbiology laboratories to ensure the highest standards of product quality through physical, chemical, and biological testing. The position requires overseeing laboratory testing activities to support manufacturing processes while maintaining strict compliance with protocols, cGMP, and safety regulations. The incumbent will be responsible for coordinating testing of raw materials, packaging, intermediates, bulk, finished, and rejected products, as well as executing and approving all laboratory investigations and documentation. Leadership and training of laboratory personnel are key aspects of this role, alongside collaboration with production, sales, quality assurance, and HR departments to maintain product quality and address any customer complaints.

Key Responsibilities

- Manage, plan, and direct Quality Control and Microbiology laboratories to ensure compliance and quality standards.
- Oversee testing of starting materials, packaging, intermediates, bulk, finished, and rejected products.
- Execute and approve laboratory investigations, review and sign lab documentation.
- Review and approve protocols and reports related to method validation, method transfer, process validation, and stability studies.
- Provide leadership, management, evaluation, and training to all laboratory employees.
- Evaluate batch manufacturing records (BMRs) as part of the product release process.
- Ensure products are manufactured according to SOPs and meet required specifications.
- Approve quality control procedures including sampling, testing, and specifications.
- Develop and maintain laboratory instructions, policies, procedures, and SOPs, including those for instrument operation and calibration.
- Arrange and verify calibration of quality control and analytical equipment.
- Coordinate with Plant Manager and Production to maintain product quality.
- Investigate and coordinate with Sales, Quality Assurance, and Production regarding customer complaints.
- Collaborate with HR and Plant Manager for annual performance appraisals and manage leave approvals for QC staff.
- Oversee endotoxin testing, sterility testing (traditional and rapid methods), and visual inspection of sterility samples, ensuring proper documentation and reporting.
- Manage environmental monitoring, growth promotion, bioburden testing, and microbial identification processes, including sending samples to qualified external laboratories.
- Prepare quarterly testing reports, monthly trend analyses, and review/revise microbiology SOPs regularly.
- Ensure gowning qualification and aseptic technique verification for cleanroom personnel and new hires.
- Supervise qualification of pharmacy technicians, including media fill tests and related documentation.
- Maintain microbiology laboratory equipment and temperature logs for chemical and microbiology labs.
- Oversee testing of raw materials, intermediates, and finished products using pharmacopoeias and instrumental techniques such as HPLC, IR, and UV.
- Prepare quality reports, analytical reports, Certificates of Analysis (CoA), and stability reports, securing necessary approvals.
- Develop and validate analytical methods and conduct stability testing for new formulations and ongoing trials.
- Write and review analytical specifications and SOPs for the QC department.
- Ensure compliance with company SOPs and maintain laboratory equipment.

Required Qualifications

- Proven experience in managing Quality Control and Microbiology laboratories within a regulated environment.
- Strong knowledge of cGMP, SOP development, and compliance standards.
- Expertise in analytical testing techniques including HPLC, IR, UV, and microbiological methods.
- Experience in method validation, method transfer, process validation, and stability studies.
- Leadership skills with the ability to train and manage laboratory personnel effectively.
- Ability to coordinate cross-functionally with production, quality assurance, sales, and HR teams.
- Strong documentation, reporting, and investigation skills.

Preferred Qualifications and Benefits

- Experience in pharmaceutical or related industries is highly desirable.
- Familiarity with environmental monitoring, endotoxin, sterility, and bioburden testing protocols.
- Hands-on experience with calibration and maintenance of laboratory and analytical equipment.
- Full-time position offering a monthly salary range of Rs130,000 to Rs150,000.
- Work location is on-site, requiring in-person attendance.

This role offers an opportunity to lead critical quality assurance functions in a dynamic laboratory environment, ensuring product integrity and regulatory compliance.