Head of Quality Assurance

Functional Competencies:

 Develop, implement, maintain, and improve Quality audit, maintain GMP quality systems and Behavioural GMP aspects

 Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories and any other outsourced activities, Internal Audits, compliance audits,

 Responsible for coordination and finalization for Qualified Person audits and Regulatory Inspections.

 Responsible for CAPA close out for all audits and inspections

 Develop, maintain and improve 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 programme

 Oversee investigations of all non-conformances (deviations, complaint etc.).

 Responsible for handling Product Recall

 Create and maintain 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.

 To 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

 Develop, implement, maintain, and improve Quality audit, maintain GMP quality systems and Behavioural GMP aspects

 Coordinate and perform all vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories and any other outsourced activities, Internal Audits, compliance audits,

 Responsible for coordination and finalization for Qualified Person audits and Regulatory Inspections.

 Responsible for CAPA close out for all audits and inspections

 Develop, maintain and improve 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 programme

 Oversee investigations of all non-conformances (deviations, complaint etc.).

 Responsible for handling Product Recall

 Create and maintain 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.

 To 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.

 To review, approval and issuing the Batch Manufacturing Record / Batch Packaging Record.

 Responsible for OOS and OOT

 To organize review meeting and document their actions and corrective measures implemented for cGMP requirements.

 To monitor the IPQA activities, review and report.

 Responsible and is nominated by management as cGMP administrator.

 Responsible for 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

 Responsible for conducting Transport validation, Review and finalize the protocol /Reports

 Responsible for National and International Manufacturing Licencing activities along with Regulatory Affairs team for the Site and Archival

 Responsible for Quality Agreements and Vendor Agreements and adherence  Responsible for All dispatches of Finished Products as per country specific approvals.