Sandeep Deore

Passionate to work for an organization with commitment and dedication to management objectives & improving skills of individual to work efficiently by self-Initiation.

Presently associated with Piramal Pharma Limited, Digwal, Hyderabad as Head Quality (Associate General Manager) since December 2021.

Passionate Professional with 21 years of experience in API pharmaceuticals industry. Presently heading Quality for CDMO and PNS vertical at site. In addition, also responsible for overall compliance of the site, internal and external audits, document control, archival management, and implementation of new projects.

Responsible for Analytical Quality assurance for the site.

Site DICO (Data integrity coordinator). Responsible for proactive assessment of site systems and processes to encourage and assure DI free culture. Responsible for handling of DI deviations, bringing them to the level of regulatory expectations and fixing the concrete CAPA.

In-depth Quality Assurance Specialist with success in prioritization and multitasking. Exceptional communication and organizational skills. Committed to paying impeccable attention to reviews and auditing procedures.
Thorough Quality Assurance Specialist with 21 year background in API pharmaceutical industry. Excellent resource management and allocation skills. Outstanding communication, organizational and time management talents. Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise. Leading Quality assurance team of 60+ teammates. Dealing with various national and international clients and persuading them for Quality related issues. Significant exposure to Contract manufacturing and development projects (CDMO). Satisfying the queries and questions of customers. Keeping the customers delighted. Significant exposure to Quality control operations, compliance, and Manufacturing. Significant exposure for leading the overall Quality function (QA and QC both) for the site for more than 2.5 years in my previous experience with Lupin. Lead the IT compliance (Computer system validation) at site in experience with Lupin. Worked with leading pharma industries like Ranbaxy, Zydus Cadila, Lupin, and Sun pharma. Good exposure of Manufacturing, Quality assurance, Quality control and IT compliances areas. Problem solver. Diversified exposure of trouble shooting and problem solving. Considerable exposure to regulatory audits like TGA, USFDA, MHRA, EDQM, KFDA etc. Representing site for various national and international customers and regulatory audits/Visits. Represented almost 300+ national and international customer audits and around 10 regulatory audits including USFDA 5 times. Having extensive exposure to all key areas of QA like, QMS (OOS, OOT, Deviations, Market complaint, CAPA), Qualifications, investigations, risk assessment, vendor qualification etc.

Having good knowledge of handling of SAP, QAMS, Caliber online documentation system, Track wise, and Ensur. Actively involved in execution of data integrity projects. Very effective in people management and administration. Appreciating peoples and taking feedback from various sources in the team is my key take away from professional experience. Excellent communication skills and good academic record. Well versed with cGMP requirements & Quality activities with respect current expectations of the regulators.

• Mr. Manish Kumar Shah, GM, Glenmark, 9617770541
• Mr. Sanjay Patel, Director, Quality, Amneal Pharma, US, 9879618592