Our Client is a leading pharmaceutical organization with multiple state-of-the-art injectable plants committed to delivering high-quality products. We are dedicated to maintaining robust quality assurance standards and compliance with regulatory requirements in all our operations.

Position Overview: We are seeking an experienced General Manager for CQA (Corporate Quality Assurance) Validations and Qualifications. The successful candidate will lead all validation and qualification activities across our injectable facilities, ensuring adherence to global and corporate policies while achieving the highest standards of quality.

Key Responsibilities:

1. Leadership and Strategy:
   • Develop and implement comprehensive validation and qualification strategies for all injectable products.
   • Provide mentorship and guidance to the CQA team, fostering a culture of quality and compliance.
   • Responsible for harmonizing the equipment/ utilities validation procedures across the manufacturing sites as per its design and intended use.

1. Validation & Qualifications:
   • Oversee and ensure successful execution of validation protocols including equipment, process, cleaning, and software validation.
   • Lead Media Fill studies and evaluate results to confirm aseptic processing capabilities, ensuring compliance with industry standards.
   • Must be experience in Equipment Qualification, HVAC, Utility qualification for Sterile drug products.
   • Responsible for preparation of required corporate procedures for equipment and utility qualification.
   • Responsible for reviewing the site qualification documents like URS, DQ, IQ, OQ, PQ and Requalification of direct impact system.
2. Regulatory Compliance:
   • Ensure all validation and qualification activities meet current regulatory requirements (FDA, EMA, etc.) and applicable corporate policies.
   • Prepare for and participate in regulatory inspections and audits, ensuring a state of readiness for compliance.
   • Oversight on execution of validation activity is carrying out as per the annual validation and revalidation planner as per Validation Master Plan.
3. Global and Corporate Policies:
   • Implement and uphold global quality assurance policies across all facilities, tailoring them as necessary to fit local regulations and practices.
   • Take a proactive approach to continuous improvement of validation processes in line with corporate quality initiatives.
4. Cross-Functional Collaboration:
   • Collaborate with R&D, Manufacturing, and Quality Control teams to ensure seamless integration of quality practices throughout the product lifecycle.
   • Liaise with stakeholders to communicate validation strategies and results, facilitating informed decision-making.
5. Training and Development:
   • Design and deliver training programs for staff on validation processes, regulatory requirements, and best practices in quality assurance.
   • Stay current with industry trends and advancements in validation methodologies to enhance departmental capabilities.

Qualifications:

• Engineering, or related field; an advanced degree is preferred.
• Minimum of 18 years of experience in the pharmaceutical industry, specifically in validation and quality assurance, including significant expertise in injectable products.
• Proven track record of leading Media Fill activities and successfully managing validation projects in a regulated environment.
• Well-versed with Sterility assurance and contamination control strategy.
• Strong familiarity with applicable regulations and guidelines (GMP, ICH, etc.) and their impact on product quality.
• Excellent leadership, project management, and communication skills, with the ability to collaborate effectively across functions and levels.
• Experience in implementing corporate policies and continuous improvement initiatives within a manufacturing setting.