Deputy General Manager, Quality Control (Lead QCC)

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:

• B. Pharma/ M.Sc/ M. Pharma

Experience:

• 16 to 22 years in injectable/ sterile/ parenteral QC Department of USFDA approved plant.