Quality Control Head/General Manager

We are seeking an experienced Quality Control Head/General Manager to lead the quality assurance department for a leading company in the pharmaceutical industry. This role requires a PhD/MSc in Analytical Chemistry, Pharmaceutical Chemistry, or a related field, and at least 15-25 years of experience in quality control and assurance.

Key Responsibilities

• Team Management: Lead and manage the QA team, ensuring adherence to quality standards and regulatory requirements.
• Process Oversight: Develop and implement quality control processes and procedures to ensure compliance with FDA, WHO, and cGMP standards.
• Audit and Compliance: Conduct audits and inspections to verify compliance with regulatory requirements and GLP practices.
• Cross-Functional Collaboration: Work with cross-functional teams to resolve quality issues and drive continuous improvement.
• Documentation Management: Maintain and update quality documentation and records to ensure accurate and compliant reporting.
• Regulatory Awareness: Stay informed about industry trends and regulatory changes to maintain compliance with FDA regulations and international standards.
• Testing and Approval: Oversee testing, approval, and rejection of finished products, raw materials, and packaging materials.
• Deviation Management: Investigate and file Deviation and Out of Specification (OOS) reports as required.
• CAPA Implementation: Develop and implement Corrective and Preventive Actions (CAPA) to address and prevent issues.
• SOP Review: Regularly review and update Standard Operating Procedures (SOPs) to reflect current practices and regulations.
• Training and Development: Ensure training for personnel on SOP changes and quality procedures.
• Analytical Work: Review analytical work and documentation, and approve analytical reports.
• Change Control: Initiate, review, and implement change control processes as necessary.
• Documentation Practices: Ensure online documentation and record keeping for QC lab and shop floor activities.
• Cost Management: Implement budgetary control and cost reduction measures for the quality department.
• Vendor Audits: Conduct vendor audits as part of the Vendor Qualification process.
• Validation Knowledge: Possess a strong knowledge of Method Validation, Cleaning Validation, and Technology Transfer.

Required Skills and Qualifications

• PhD/MSc in Analytical Chemistry, Pharmaceutical Chemistry, or a related field.
• 15-25 Years Experience in Quality Control and Quality Assurance roles.
• Expert Knowledge in cGMP and GLP requirements.
• Strong Understanding of FDA Regulations, WHO Guidelines, and international quality standards.
• Experience in Testing and Approval of Finished Products, Raw Materials, and Packaging Materials.
• Expertise in CAPA and Deviation Management.
• Proficiency in SOP Review and Quality Training.
• Strong Analytical Skills and Experience with Analytical Reports.
• Knowledge of Change Control and Documentation Practices.
• Experience in Cost Management and Budgetary Control.
• Vendor Qualification and Audit Experience.
• Method Validation and Technology Transfer expertise.

Preferred Qualifications

• Extensive Experience in leading QA teams and managing quality control processes.
• Expertise in Conducting Audits and maintaining regulatory compliance.
• Advanced Knowledge of Method Validation and Cleaning Validation processes.
• Experience in a Senior Management Role within a pharmaceutical or related industry.

How to Apply

If you are a qualified professional with a strong background in quality control and are ready for a leadership role, apply now for this exciting opportunity!