General Manager-Quality

• May 2022 - Present

- Overall responsibility over the Quality activities of the site, managing and leading the department. The role is a member of the Site Leadership Team and reports solid line into the Global Head of Quality function. -Responsible to prepare a strategic long-term plan to further strengthen the Quality system in the organization. Responsible to prepare the yearly quality plan, taking local and global requirements into account. -Responsible to translate all the relevant Global Policies, Standards and Procedures into the Organization. Responsible to build a strong team of professionals and ability to lead them to ensure that all facets of quality, like Assurance, Control, documentation, Vendor Audits, Customer Audits are handled with required rigor. • Responsible to evaluate and prioritize quality projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives. • Responsible for the development and implementation of improvement systems in the area in line with the Operational Excellence strategy. •As a Key Management Personnel position, responsible to ensure the Systems are inline with GMP requirements and provide overall management and leadership for the GMP Manufacturing. • Responsible for qualifying the suppliers as part of the vendor evaluation strategy for the global sites. Responsible for a Foster a safe and compliant culture in the workplace Show less

Deputy General Manager-Quality

• Apr 2019 - Jul 2022

Asst.General Manager-Quality

• Apr 2016 - Mar 2019

-Responsible for managing quality aspects at Granules OmniChem and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Ajinomoto Omnichem Quality Guidelines and is conducted according to the relevant SOPs -Responsible for managing quality aspects at Granules OmniChem and to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Ajinomoto Omnichem Quality Guidelines and is conducted according to the relevant SOPs

Sr.Manager-Quality

• Jul 2014 - Mar 2016

Quality functions Quality functions

Sr. Manager-QA & Compliance

• Apr 2012 - Jul 2014

-Maintain a high level of QMS (Quality Management System) knowledge and awareness of changes within the commercial environment to seek opportunities and manage potential business adversity. ▪ Act in the role of the Quality Head and Qualified Person in the absence of the Technical Director. ▪ Ensure that all SOPs are in place, updated & training has been conducted across the business. ▪ Promote QMS management principles and seek continuous improvement of the processes. ▪ Review, conduct impact assessments and implement any updates to QMS policies. ▪ Manage Review meetings according to local SOPs. ▪ Identify, Implement and Manage QA Objectives & KPIs. ▪ Establish and manage Annual Quality Plans. ▪ Ensure that all SOPs and systems in use and compliant to the QMS and local regulatory requirements, including: - Management Review Meetings; - Change Control Management; - Risk Management; - Complaints and Incident management; - Product supply. ▪ Auditing - Ensure the auditing process includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management; suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited (Audits L1 and L2 Internal Certification); ▪ Responsible for the review, approval of Quality Agreements and liaison with manufacturing sites to ensure compliance to local registered technical details. Show less

Dy.Manager-QA

• Jul 2010 - Apr 2012

Looking after the QMS function for the site at hyderabad Looking after the QMS function for the site at hyderabad

Deputy Manager-QA

• Feb 2008 - Jul 2010

-Audit Management -Equipment Qualification and Validations -Plant QMS functions -Market Complaints and Returns -Supplier Evaluation & Qualification -Audit Management -Equipment Qualification and Validations -Plant QMS functions -Market Complaints and Returns -Supplier Evaluation & Qualification