Deputy QA Manager for API Pharmaceutical Plant

We are seeking a highly skilled and experienced Deputy QA Manager for our API pharmaceutical plant. The primary responsibility of this role is to establish and maintain a robust quality management system to ensure the production of safe, effective, and compliant API products. The ideal candidate will have a strong background in pharmaceutical QA, regulatory compliance, and continuous improvement.

Key Responsibilities:

1. Quality Assurance Strategy:
   • Develop and implement a comprehensive quality assurance strategy and quality management system to ensure compliance with regulatory requirements, industry standards, and company policies.
2. Compliance Management:
   • Ensure all manufacturing processes, documentation, and testing procedures comply with relevant regulatory standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ICH guidelines.
3. Standard Operating Procedures (SOPs):
   • Develop and maintain SOPs for quality control, quality assurance, and quality management activities. Ensure these procedures are consistently followed throughout the plant.
4. Audits and Inspections:
   • Coordinate and conduct internal and external audits to assess compliance with regulatory requirements and identify areas for improvement.
   • Prepare for and manage regulatory inspections by health authorities or customers.
5. Quality Control:
   • Oversee quality control activities, including raw material testing, in-process checks, and final product testing.
   • Ensure appropriate analytical methods and equipment are in place and validated.
6. Deviation and CAPA Management:
   • Manage the deviation and Corrective and Preventive Action (CAPA) system, including investigating deviations, identifying root causes, and implementing corrective actions to prevent recurrence.
7. Training and Personnel Development:
   • Provide training and support to personnel on quality systems, regulatory requirements, and quality-related procedures.
   • Foster a culture of quality and continuous improvement within the organization.
8. Documentation and Record Keeping:
   • Ensure accurate and timely documentation of all quality-related activities, including batch records, test reports, and validation protocols.
   • Maintain a systematic record-keeping system for easy retrieval and compliance.
9. Supplier Management:
   • Collaborate with procurement and supply chain teams to establish and maintain a supplier qualification program, ensuring all raw material suppliers meet quality standards and specifications.
10. Risk Management:
    • Identify and assess quality risks within the manufacturing processes, implement risk mitigation strategies, and drive continuous improvement initiatives.
11. Quality Metrics and Reporting:
    • Define and track key quality performance indicators (KPIs) to measure the effectiveness of quality systems and report on quality trends to senior management.
12. Continuous Improvement:
    • Drive a culture of continuous improvement by initiating and leading quality improvement projects, conducting root cause analyses, and implementing best practices.
13. Regulatory Compliance:
    • Stay up to date with regulatory changes and industry trends in quality assurance and ensure the plant’s readiness for upcoming regulatory requirements.
14. Collaboration and Communication:
    • Foster effective cross-functional collaboration with departments such as production, engineering, regulatory affairs, and quality control.
    • Communicate quality-related issues, initiatives, and improvements to stakeholders at all levels.
15. Authorisation and Approval:
    • Authorize SOPs for the Production, Store, and Maintenance Departments.
    • Approve SOPs for the QC/QA Departments.
    • Validate vendors for raw materials and packing materials.
    • Oversee the calibration and validation of equipment in the Production and QC Departments.
    • Qualify the purified water system.
    • Validate the air handling system for liquid and powder manufacturing and filling sections.
16. Waste Management:
    • Ensure proper disposal of rejected raw materials.
    • Ensure production cleaning procedures are strictly adhered to without deviation.
    • Account for production rejections and waste and implement plans to reduce them.
    • Resolve production issues in collaboration with Maintenance, QA/QC departments.
17. Analytical Chemist Validation:
    • Validate analytical chemists’ work and ensure compliance with quality standards.
18. Quality Standards Implementation:
    • Create and implement company quality standards.
    • Accomplish quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
    • Train and motivate employees to ensure quality standards are met.
    • Validate quality processes by establishing product specifications and quality attributes.
    • Maintain and improve product quality through product, company, system, and compliance audits.

Qualifications:

• Education: Bachelor’s or Master’s degree in Chemistry, Pharmacy, or a related field.
• Experience: Minimum of 10-20 years of experience in pharmaceutical quality assurance, with at least 1 years in a managerial role within the API sector.
• Knowledge:
  • Thorough understanding of GMP, FDA, EMA, and other regulatory requirements.
  • Strong knowledge of quality management systems and quality control procedures.
• Skills:
  • Excellent analytical and problem-solving skills.
  • Strong leadership and team management capabilities.
  • Effective communication and interpersonal skills.
  • Proficient in quality management software and Microsoft Office Suite.

Working Conditions:

• This position may require occasional travel for audits, inspections, and training.
• Must be able to work in a laboratory and production environment, adhering to safety and quality standards.