Team Lead -Deviation & CAPA

To lead and oversee the Quality Assurance Compliance team in ensuring that all operations comply with cGMP, GDP, ISO, and regulatory requirements . The QA Compliance Process lead is responsible for supervising quality system activities, managing audits and inspections, and driving continuous improvement initiatives to maintain a high standard of quality compliance across the organization.

Quality System Oversight

• Lead and manage daily QA compliance operations, ensuring adherence to company and regulatory requirements.
• Oversee the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Supervise review and closure of deviations, market complaints, CAPAs.
• Ensure quality system data is analyzed, trended, and reported through compliance KPIs and management reviews.
  
  

Audits and Inspections

• Plan, coordinate, and lead internal audits and self-inspections according to the annual audit schedule.
• Prepare the organization for regulatory inspections and customer audits; coordinate responses and follow-up on findings.
• Review and approve audit reports and ensure timely and effective implementation of corrective and preventive actions (CAPAs).
  
  

Documentation and Records Management

• Supervise the control, review, and approval of SOPs, quality manuals, and other controlled documents.
• Ensure compliance with Good Documentation Practices (GDP) and manage document lifecycle from issuance to archival.
• Support departments in documentation compliance and timely updates of controlled procedures.
  
  

Training and Team Leadership

• Lead, coach, and develop the QA Compliance team, ensuring adequate training and competency development.
• Conduct and facilitate GMP and compliance-related training sessions for staff across departments.
• Foster a quality culture that emphasizes compliance, accountability, and continuous improvement.
  
  

Continuous Improvement and Risk Management

• Lead or participate in quality improvement and risk management projects.
• Identify compliance gaps and propose systematic solutions.
• Ensure proper implementation of data integrity principles (ALCOA+) across all quality systems.
  
  

Environmental, Health And Safety Responsibilities

• Follow the company’s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
• Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
• Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initiatives.
• Leadership and Accountability
• Quality and Compliance Focus
• Continuous Improvement Mindset
• Collaboration and Cross-Functional Coordination
• Integrity and Professionalism
• Bachelor’s or Master’s Degree in Pharmacy, Chemistry, Biology, Biotechnology, or a related or equivalent field
• Minimum 5-10 years of experience in Quality Assurance / Compliance within the pharmaceutical or biotechnology industry, including at least 2–3 years in a supervisory or team leadership role.
• Comprehensive understanding of GMP, GDP, and ISO 9001 and ISO 14001 requirements
• Strong familiarity with regulatory guidelines (FDA, WHO, EU).
• Experience in audits, CAPA, risk management, and QMS systems.
• Excellent leadership and team management skills.
• Strong communication, coordination, and decision-making abilities.
• Analytical thinking and problem-solving skills.
• Proficiency in MS Office and electronic QMS platforms.