Director of Quality Assurance

We are seeking a seasoned Quality Assurance leader to oversee the development and implementation of quality audit programs, maintain GMP quality systems, and ensure compliance with regulatory requirements.

The ideal candidate will have excellent leadership skills, ability to motivate and guide a team, and strong analytical and problem-solving skills.

• Develop and implement quality audit programs to ensure compliance with regulatory requirements
• Maintain GMP quality systems andBehavioural GMP aspects
• Coordinate vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories, and any other outsourced activities
• Perform internal audits and prepare for regulatory inspections
• Lead CAPA close out for all audits and inspections
• Develop and maintain a GMP compliant document control system
• Establish a robust Quality Management System (QMS) to manage and implement change management, Deviation management, Incidents, complaint handling, and CAPA management
• Responsible for All GMP trainings and Quality training program
• Oversee investigations of all non-conformances (deviations, complaints etc.)
• Responsible for handling Product Recall
• Create and maintain a system to implement requirements of ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)
• Ensure that cGMP requirements and quality standards are recognized, understood, and maintained across the Company
• Develop batch Release and Reject system to ensure quality product is released to the market
• Work across all disciplines (e.g., manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes
• Lead, manage, and ensure proper training to any relevant change management programs throughout the company
• Provide quality guidance to product development projects and programs
• Responsible for Data Integrity Internal Audits, Training, and Review and Reporting to the management
• Ensure all validation activities (process/cleaning/method/equipment etc.) are carried according to approved protocols and requirements
• Well versed with requirements of Injectable products, facility requirements, and Media fill requirements
• Responsible for Technology Transfer documents compile necessary records and smooth transmission to meet and comply to regulatory requirements
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time, and cost
• Ensure development of departmental SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being - fit for purpose operationally and commercially
• Ensure that all activities are performed in accordance with GMP, company SOPs, and Health and Safety policies
• Ensure that there is a self-inspection programme in place to meet the requirements of EU GMP/PICS/TG/MHRA etc.
• Review, approval, and issuing the Batch Manufacturing Record / Batch Packaging Record
• Responsible for OOS and OOT
• Organize review meeting and document their actions and corrective measures implemented for cGMP requirements
• Monitor the IPQA activities, review, and report
• Responsible and nominated by management as cGMP administrator
• Preparation, Review, Finalization, and time to time submission of documents if any to external customers and Agencies as per Regulatory Requirements
• Responsible for adherences of Validation master plan and adherences to the Validation schedule
• Responsible for Control Sample Management (Final Retention Samples) along with QC
• Responsible for Stability Management along with QC team
• Responsible for Quality Review Meetings and Management Review Meetings
• Responsible for Documentation cell and Lifetime documents archival Programme
• Responsible for Artwork Approval and Shade card maintenance
• Responsible for Label management and Risk Management
• Responsible for Shredding and maintenance
• Responsible for Review of all Layouts along with Engineering Team
• Responsible for Review of Pest Control management, Fire Extinguisher Annual documents along with EHS, HR, and Engineering Team
• Responsible for Review and Finalization of water system validation documents along with Engineering department
• Conduct Transport validation, Review, and finalize the protocol/Reports
• Responsible for National and International Manufacturing Licensing activities along with Regulatory Affairs team for the Site and Archival
• Responsible for Quality Agreements and Vendor Agreements and adherence
• All dispatches of Finished Products as per country specific approvals

• Strong leadership skills with ability to motivate and guide a team
• Excellent communication and interpersonal skills
• Ability to work under pressure and meet deadlines
• Good analytical and problem-solving skills
• Knowledge of GMP regulations and quality systems
• Ability to develop and implement quality audit programs
• Experience in managing and coordinating vendor qualification activities
• Experience in leading internal audits and preparing for regulatory inspections
• Experience in managing and implementing change management, Deviation management, Incidents, complaint handling, and CAPA management
• Knowledge of ICH Q8 (QBD), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System)

We offer a competitive salary and benefits package, opportunities for professional growth and development, and a collaborative work environment.

Please submit your application, including your resume and cover letter, through our website.