Leadership Role - Corporate Quality Assurance - Pharma

Position : Leadership Role in CQA (Leading MNC Pharma Company)

Role :

- Overall responsible for Quality management in Operations for the Company

- Supports the implementation and maintenance of the Company's quality system in India in accordance with the Company's Global quality system and local quality requirements

- Ensure in-time implementation of all QA requirements

- Ensure compliance with GxP guidelines and regulations

- Ensure compliance with Business Ethic requirements

- Ensure Quality compliance during product transportation

- Manage the validation status of IT systems and products related to Handling of Quality related IT systems

- IT&Q responsibility

- Handling QMS compliance

- Ensure PSR compliance regarding Handling, Storing, packaging protecting and delivering products

- Report and follow up on Deviations and ensure effective implementation of Systematic Problem Solving methods for Deviation investigation

- Ensure effective implementation of root cause analysis and respective CAPA

- Ensures that current QA requirements are available, communicated and implemented and any update /change to the requirements are detected and implemented to the system properly

- Train employees in QA matters, responsible for induction trainings in QMS

- Ensure Quality compliance with Audits

- Responsible for Self Inspections

- Responsible for Document control Compliance

- Responsible for Quality Assurance related to repackaging of products

- Support making local procedures and ensure employees complying with procedures

- Supervise reporting of Customer Complaints in accordance with the Company's requirements

- Team Management

- Participate in strategic decisions and translate them into short and long term business priorities for the team

- Analyze new regulations with potential impact on the Quality Management Systems of the Company

Requirements :

- 11+ yrs of experience in Corporate Quality in a Pharma Company

- Should have relevant certifications in Quality Management

- Trained in ISO standards and / or certified and experienced lead auditor

- Should be good at team management

- Should have good understanding of quality risks and how they can impact business

- Ability to communicate complex issues in a simple and understandable manner

- Experience of Clinical Quality Assurance

- Should have worked in Pharmaceutical industry

Location : Bangalore