We are hiring - Manager - Validation & Qualification

Location: Karachi Division, Sindh, Pakistan (On-site)

Position Summary:
To lead Qualification and Computerized System Validation (CSV) activities across the facility. The incumbent will be responsible for overseeing equipment and utilities qualification, ensuring full compliance with regulatory standards such as WHO and PIC/S, and driving a culture of quality and continuous improvement. This role also involves implementing the Qualification Review Program (QRP) across all sites, harmonizing validation practices, and strengthening the CSV framework. Additionally, will play a key role in developing and enhancing the capabilities of validation personnel through structured competency frameworks, while ensuring efficient execution of validation strategies aligned with organizational objectives.

Job Responsibilities:
. Lead and manage end-to-end qualification and CSV activities, including planning, execution, and lifecycle management of equipment, utilities, and computerized systems.
. Develop and implement validation strategies in line with regulatory requirements and industry best practices.
. Ensure compliance with applicable guidelines (WHO, PIC/S) and internal quality standards.
. Review and approve Validation Master Plans (VMP), qualification protocols (DQ, IQ, OQ, PQ), reports, SOPs, and related documentation in accordance with Good Documentation Practices (GDP).
. Oversee commissioning and qualification of new equipment, utilities, HVAC systems, water systems, and gases.
. Coordinate cross-functional teams (Engineering, Production, QA, IT) to ensure smooth execution of validation and qualification activities.
. Establish and drive the Qualification Review Program (QRP) across all sites to ensure ongoing compliance and requalification.
. Lead harmonization and continuous improvement of Computerized System Validation (CSV/CSA) processes across the organization.
. Identify gaps, implement corrective and preventive actions (CAPA), and support change control and risk assessment activities within the QMS framework.
. Monitor project timelines, allocate resources effectively, and ensure timely completion of validation deliverables.
. Act as Subject Matter Expert and provide technical guidance, training, and mentorship to validation team members.
. Support internal and external audits by ensuring readiness of validation documentation and addressing audit observations.
. Drive process optimization initiatives and contribute to overall operational efficiency (OEE improvement).

Required Qualification, Knowledge and Skills:
. Pharm-D or Master's degree in Chemistry, Applied Chemistry, or a related scientific / Engineering discipline from an HEC-recognized university.
. 8-10 years of overall experience in validation, qualification, or quality assurance within a pharmaceutical or biotech manufacturing environment, including 2-3 years in a managerial or leadership role overseeing cross-functional teams, managing multiple validation projects, and ensuring timely execution of validation strategies.
. Strong hands-on experience in HVAC commissioning and qualification, including system design review, installation checks, and performance verification as per regulatory requirements.
. In-depth knowledge of water systems and process gases qualification, including generation, storage, distribution, and monitoring in compliance with GMP standards.
. Proven expertise in cleaning validation, including development of protocols, execution, sampling strategies, and acceptance criteria.
. Sound understanding of calibration and verification practices for instruments and equipment to ensure accuracy, reliability, and compliance.
. Comprehensive experience in Computer System Validation (CSV/CSA), including risk-based validation approaches, system lifecycle management, and data integrity principles.
. Demonstrated ability in process optimization and improving Overall Equipment Effectiveness (OEE) through data- driven analysis and continuous improvement initiatives.
. Strong knowledge of Validation and Quality Management Systems (QMS), including risk assessments, change control, deviations, and CAPA management.
. Working knowledge of AutoCAD for reviewing layouts and engineering drawings will be considered an added advantage.