Visakhapatnam

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

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.

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.
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 ou

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