Description
Responsible for leading and overseeing the day-to-day operations of the QC laboratory to ensure compliance with regulatory standards, including cGMP and GLP. This role will support manufacturing teams to guarantee the production of high-quality products by ensuring that testing, protocols, and procedures align with industry standards. Will guide, train, and develop laboratory personnel, ensuring continuous improvement of the quality system and maintaining a culture of compliance across all functions. Additionally, this role will be pivotal in managing audits, regulatory readiness, and the efficient execution of validation studies. Will play a critical role in reviewing and approving raw materials, intermediates, and finished products, ensuring timely and accurate testing while managing OPEX/CAPEX budgets for QC activities.
Essential Functions
- Lead the QC laboratory, ensuring continuous compliance with regulatory standards (cGMP, GLP).
- Support manufacturing teams to ensure high-quality production.
- Guide and train QC personnel to enhance the quality system.
- Organize meetings to resolve quality-related issues and ensure regulatory readiness.
- Lead regulatory and customer audits, ensuring readiness for quality product delivery.
- Implement and harmonize quality standards, ensuring system compliance.
- Review SOPs and protocols for regulatory compliance.
- Oversee process, cleaning, and hold time validation studies.
- Ensure compliance with quality metrics and laboratory systems.
- Manage OPEX/CAPEX for QC, adhering to budgetary norms.
- Monitor and update procedures based on current pharmacopeia and regulatory guidelines.
- Ensure testing of batches aligns with specifications, STP, SOPs, and cGMP.
- Oversee timely testing of raw materials, packing materials, and intermediates.
- Ensure finished product analysis complies with established procedures.
- Approve/reject raw materials, intermediates, and finished products.
- Manage change controls, deviations, and closure actions.
- Oversee laboratory investigations (OSS, OOT, OOAL).
- Ensure effective CAPA implementation and customer complaint resolution.
- Support QA in responding to regulatory/customer queries and observations.
Additional Responsibilities
- Develop and mentor laboratory staff to meet departmental and organizational goals.
- Drive continuous improvement and operational excellence initiatives. -
- Ensure compliance with electronic data management -
- Organize meetings to review and update GLP practices
- Ensure AMC/CMC for laboratory equipment as applicable.
- Conduct training on ICH, 21 CFR, and internal QC procedures.
Skills
- Regulatory Compliance - Advanced
- Quality Control Process Optimization - Mastery
- Supplier Quality Management - Advanced
- Audit and Inspection Management - Mastery
- Technology Integration and Automation - Advanced
- Change Control & CAPA Management - Advanced
- SOP Development & Document Management - Advanced
- Analytical evaluation of vendor - Advanced
- Training and Compliance Record Management - Advanced
- Documentation & Data Integrity - Mastery
- CAPA, Deviation, and Change Control Management - Advanced
- Specifications & Test Methods Documentation - Advanced
- Deviation Management - Mastery
- Change Management - Mastery
- Knowledge of ICH, 21 CFR, and QC procedures - Expert
- Knowledge of GMP & GDP Guidelines - Expert
- Team Management - Expert
Education
QUALIFICATIONS
- B. Pharma/ M.Sc/ M. Pharma
Experience
- 16 to 22 years in injectable/ sterile/ parenteral QC Department of USFDA approved plant.
