Appendix A – Details of the Employment history

Location; The Netherlands

• Responsible for Quality Compliance Management and Regulatory Affairs activities across Business Unit Europe America (BU EA) sites, including CMOs (2 locations in Spain, 2 locations in Italy, 1 location in Netherlands, 2 locations in India)
• Member of Management Team for BU EA
• Supporting manufacturing sites for GMP trainings, GMP audits and facilitating the authority inspections
• Qualifying suppliers of starting materials, intermediates and key raw materials
• Regulatory strategies and registrations of DSP products with Global regulatory authorities like EDQM, USFDA, KFDA, ANVISA, Russia, Cofepris, SFDA, Canada and EU member states
• Interaction with regulatory authorities for technical advice
• Interactions with USP & EP monographs for providing reference standards and participating in the collaborative studies, related to DSP products
• Preparing information disseminations and global impact reviews for upcoming / revisions of the applicable guidelines and updating the processes
• Team Lead for implementation of IT tool RIMS (Regulatory Information Management System) from Veeva
• Performance reviews of the processes and the teams
• Performing the regular internal audits of manufacturing sites

Sr. Manager International Quality & Regulatory Affairs- June 2011 till October 2016.

Location; The Netherlands

Global responsibility in a Senior Management role, responsible for:

• Establishing the Quality Management System (QMS) and procedures from scratch to build-up new business function of Drug Product (Pre-mixes and Oral dosages). Qualification of CROs (drug development & clinical), CMOs, suppliers and vendors. Establishing Quality agreements
• Compliance monitoring / International quality audits of all sites across the Globe
• Interaction with R&D, Review of development reports and validation activities for drug substance and drug products
• Establishing the regulatory & quality strategies and providing support for execution
• Supporting the preparation of CMC part of the dossiers, reviews for submission & response documents
• Aligning with New Developing APIs for Drug Product strategies for Regulatory submissions and Quality support
• Technical support and development of new customers
• Global responsibilities for our own manufacturing and third-party operations in China, India, Spain, Italy, Netherlands, USA and Mexico for quality compliance monitoring, trouble shootings and GMP trainings

Manager International Regulatory Affairs- June 2009- June 2011.

Location; The Netherlands

Responsible for DAI Global operations for APIs (Netherlands, Sweden, Spain, Italy, Egypt & India). Interacting with USFDA, EU, Brazil, Ukraine, Belarus, Japan, SFDA China regulatory authorities. Close cooperation’s with Business development, customers and sites.

Responsible for:

• Regulatory advice for current as well as new product introductions
• Interacting with R&D for regulatory needs form the basics
• Prepare & review of the regulatory submissions
• Customer support for EU & US registrations
• Liaison with regulatory authorities.
• Interpretation of guidelines and updates
• Trainings regarding applicable guidelines.
• Internal Regulatory audits
• Facilitating the regulatory authorities’ audits.
• Compliance policies and procedures

Team lead – Quality Management as SAP BPE (Business Process Expert) - December 2007-June 2009

Location; The Netherlands

Designing the SAP business process flow for Quality Module aligning with cGMP requirements, customization reviews, writing scripts, testing the processes, validations as per GAMP & CFR part 11, training for implementation. Successful Implementation performed at DAI sites in India, Spain, Netherlands, Egypt and Italy.

Technical Sales Service Manager - November 2004 – December 2007

Location; The Netherlands

Responsible for USA, Canada, Europe, Middle East and Turkey market for all products of DAI. Key job responsibilities included Technical support to customers regarding DAI products for addressing quality issues, application issues with Finish Dosages, registration requirements, coordinating qualification audits, new product / new grade introduction, developing new business opportunities.

Coordination with DAI manufacturing sites to share the customer’s voice. Sharing new technical developments with the business. Integrating R&D activities with performance needs of customers, developing new grades, benchmarking activities for continual improvements. Training to the marketing & sales force and developing business models.

DSM Anti-Infectives India Limited (DAI-India) - August 1996 to November 2004

Location: India

Leader – Quality (QC/QA) & Regulatory Affairs

Functional Head and Management Representative for ISO 9001 QMS & ISO14001 EMS. Member of Management Team (MT) of DAI India, reporting to Chief Executive Officer

• Establishing the Systems for meeting the desired Quality standards aligning the Local laws, ISO 9001:2000 QMS standards, International Quality standards as per ICH and the corporate policies, by developing the procedures & controls, imparting regular training’s & coaching at all levels
• Facilitating compliance to Quality and regulatory requirements at all business processes, Strategic Quality Planning, creating employee’s Quality culture
• Monitoring of QMS and regulatory compliance at all business process, ensuring the compliance, by cross-functional audits
• Integration of Production Processes with the regulatory requirements and the customers with a collaborative approach to customer needs
• Interface with suppliers and vendors for addressing the quality at source
• Facilitation of Investigation of the Deviations, Customers complaints investigation and Benchmarking
• Preparation, review & submission of DMFs for registration of products with EDQM and to USFDA
• Facilitating the external audits by ISO certifying agencies, customers and regulatory agencies

Cepham Organic Limited - March 1994 till August 1996

Location; India

Manager - Technical Service, responsible for establishing the quality systems, new processes for manufacturing of for Cefazoline, Ampicillin using Dane salt, CMIC, L-base for Chloramphenicol, improvements projects for increased quality, enhanced capacity utilizations, trouble shootings

Alpha Drug India Limited - January 1989 till March 1994

Location; India

Joined this organization as at very inception stage of the organization, 4th technical employee to join.

• Activities involved, setting up of pilot plant and analytical lab
• Technology Absorption at lab scale under the guidance of the foreign experts and scale up to commercial level.
• Qualifications & validations of equipment’s and process. Commercialization of product.
• Developed the Quality standards from scratch

Max India Limited - November 1985 till December 1988

Location; India

Additional activities:

• Member of APIC – European API committee
• Member of the EDQM anti-counterfeiting project team
• Member of Quality Working group for ICH Q12
• Member of central ASMF review procedure, interacting with EMA. This project is now almost finished
• Speaker on behalf of Concept Heidelberg in NL
• Training faculty at NIPER in India (Compilation of DMF, performing the risk assessment)

Training’s and conferences:

Quality

• ISO 9000 – Lead Auditor – registered with IRCA UK
• APIC certified auditor training
• ICH Q7 compliance for APIs by ECA
• Particulate matters in the Drug products – ECA
• GMPs for drug products as per EU part 1 guidelines by PCS
• Drug Manufacturing conference
• Cleaning Validations
• Aseptic processing and controls

Regulatory

• European regulatory procedures by Management Forum UK
• FDA Generic drug approval process by Management Forum UK
• Filing Variations by PTI
• Pharmacovigilance – Basics
• ICH Q3D – Elemental Impurities
• Elaborations of Monographs by EDQM
• Reference standards – Concept & requirements by EDQM

Management Leadership Program