Title - Head QC (API Manufacturing) | Chandigarh

Job Location - Chandigarh

Min Exp - 15 Years in API Manufacturing

Job Overview:

We are seeking a highly skilled and experienced professional to join our team as the Head of Quality Control for our API manufacturing company. As the Head of Quality Control, you will be responsible for leading and managing all aspects of the quality control function to ensure compliance with regulatory standards and maintain the highest level of product quality. You will oversee a team of quality control professionals and collaborate with cross-functional teams to drive continuous improvement in quality processes and systems.

JOB RESPONSIBILITIES:

• Leadership and Strategy:
• Develop and implement the quality control strategy aligned with the company's objectives and regulatory requirements.
• Provide strong leadership and guidance to the quality control team, fostering a culture of quality and accountability.
• Establish and maintain quality control policies, procedures, and standards in compliance with applicable regulations and industry best practices.
• Quality Control Operations:
• Oversee the day-to-day operations of the quality control department, ensuring timely and accurate testing and release of raw materials, intermediates, and finished API products.
• Manage the qualification, calibration, and maintenance of quality control equipment and analytical instruments.
• Monitor the electronic data compliance.
• Monitor and analyze quality control data, trends, and metrics to identify areas for improvement and implement corrective actions as necessary.
• Collaborate with other departments, such as manufacturing, regulatory affairs, and R&D, to ensure alignment and timely resolution of quality-related issues.
• Regulatory Compliance:
• Ensure Laboratory compliance with applicable regulatory requirements, including but not limited to FDA, EMA, ICH, and other global regulatory authorities.
• Stay current with regulatory updates and industry trends related to quality control practices and implement necessary changes to maintain compliance.
• Lead and support regulatory inspections and audits related to quality control activities, ensuring timely preparation and appropriate responses.
• Ensure electronic data compliance with applicable regulatory requirements, including but not limited to FDA, EMA, WHO
• Team Management and Development:
• Build and manage a high-performing quality control team, providing mentorship, coaching, and professional development opportunities.
• Foster a collaborative and positive work environment, promoting effective communication and teamwork.
• Set performance goals and conduct performance evaluations for team members, recognizing achievements, and addressing performance gaps.
• Continuous Improvement:
• Drive continuous improvement initiatives to enhance quality control processes, systems, and procedures.
• Identify opportunities to optimize resources, streamline workflows, and reduce costs while maintaining high-quality standards.
• Implement quality control metrics and key performance indicators (KPIs) to monitor departmental performance and drive improvement efforts.
• Mentorship to junior analyst to foster professional development and growth.
• Requirements:
• Master’s degree in pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
• Extensive experience (15+ years) in quality control operations within the API manufacturing industry, with a solid understanding of GMP (Good Manufacturing Practices) and regulatory compliance.
• Strong knowledge of analytical techniques and methodologies used in API manufacturing and quality control, including HPLC, GC, ICP-MS, spectroscopy, and other relevant analytical instruments.
• Proven experience in leading and managing a quality control team, including hiring, training, and performance management.

Interested candidates can share profiles at [email protected] or can WhatsApp at 8629031243.