QC Manager

This role is for one of the Weekday's clients

Salary range: Rs 800000 - Rs 1100000 (ie INR 8 - 11 LPA)

Experience: 15+ yrs

Location: Navi Mumbai

Job Type: full-time

We are seeking an experienced and detail-oriented QC Manager to lead Quality Control operations within a pharmaceutical manufacturing environment. The ideal candidate will have extensive experience in pharmaceutical quality control, laboratory management, regulatory compliance, and team leadership. This role is responsible for ensuring that all raw materials, in-process samples, finished products, and stability samples meet established quality standards and regulatory requirements.

The QC Manager will oversee laboratory activities, implement quality systems, drive continuous improvement initiatives, and ensure compliance with cGMP, GLP, and applicable regulatory guidelines. The successful candidate should possess strong technical expertise, excellent leadership capabilities, and a proven track record of maintaining high-quality standards in a regulated pharmaceutical environment.

Requirements

Key Responsibilities

• Manage and oversee all Quality Control laboratory operations, including chemical, instrumental, microbiological, and stability testing activities.
• Ensure timely testing, review, and release of raw materials, packaging materials, in-process samples, and finished pharmaceutical products.
• Establish, review, and approve laboratory procedures, specifications, protocols, and reports.
• Ensure compliance with cGMP, GLP, data integrity requirements, and regulatory guidelines issued by national and international authorities.
• Lead laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and customer complaints.
• Monitor laboratory performance through key quality metrics and implement corrective and preventive actions (CAPA) where necessary.
• Manage laboratory resources, equipment qualification, calibration, maintenance, and method validation activities.
• Coordinate stability studies and ensure accurate documentation and reporting of results.
• Support regulatory inspections, customer audits, and internal quality audits by providing necessary documentation and technical expertise.
• Collaborate closely with Quality Assurance, Manufacturing, Regulatory Affairs, and R&D teams to ensure product quality and compliance.
• Develop, mentor, and manage QC teams to build a culture of quality, accountability, and continuous improvement.
• Drive initiatives for process optimization, laboratory efficiency, and implementation of best practices.

Required Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Microbiology, or a related scientific discipline.
• 15–25 years of progressive experience in Quality Control within the pharmaceutical industry.
• Significant experience managing QC laboratories and leading cross-functional quality initiatives.
• Strong understanding of pharmaceutical manufacturing processes and quality systems.

Must-Have Skills

• Quality Control (QC)
• Pharmaceutical Industry Experience
• Laboratory Operations Management
• cGMP and GLP Compliance
• OOS/OOT Investigation Handling
• Stability Studies Management
• Method Validation and Verification
• Regulatory Compliance
• CAPA Management
• Team Leadership and People Management

Good-to-Have Skills

• QC Manager-level leadership experience
• Exposure to regulatory inspections such as USFDA, MHRA, EMA, WHO-GMP, or equivalent
• Data Integrity and Quality Risk Management
• Laboratory Information Management Systems (LIMS)
• Process Improvement and Lean Quality Practices
• Project and Stakeholder Management

Desired Candidate Profile

The ideal candidate is a proactive quality leader with strong technical expertise in pharmaceutical quality control and a demonstrated ability to manage large laboratory operations. They should possess excellent problem-solving, analytical, communication, and decision-making skills, along with the ability to lead teams in a fast-paced, highly regulated environment. A commitment to quality excellence, compliance, and continuous improvement is essential for success in this role.