Manpreet Singh Naroo

Mobile: +91-987*******

Email: oy0odm@r.postjobfree.com

Quality Assurance & Audits / Regulatory Affairs / Process Excellence

Multi-functional expert with more than18 Years of accomplished experience in Pharma Sector

Executive Summary

• Seasoned and dynamic Management Executive with a gratifying career span of more than one decade predominantly in the areas Quality Systems Implementation, cGMP & Regulatory Compliance, Process Management, Auditing, General Administration and Documentation, etc.

• Significant experience of modern concepts of Quality & Value Engineering, ensuring quality of product by using tools of ICH as Validation, Equipment & Instrument Qualification, etc.; facilitated preparation of Validation/Qualification Reports and reviewed activities of qualification including Equipments, Water Systems and Air Handling Units.

• Demonstrated competencies in deriving substantial improvements across diverse business processes with implementation of latest Quality Management Tools; deft in preparing the Quality Assurance Plans (QAP), SOPs, and analyzing Customer Complaints through CAPA Plans.

• Hands on knowledge of US FDA, MHRAUK , TGA, WHO GMP, EU regulations; successfully conducted self-auditing of manufacturing / production areas, QC Lab to ensure GMP/GLP compliance; adequate experience in handling & reviewing deviations, on line rejections, change controls, OOS and OOTs , BPRs , SOPs , VMP and validation protocols; Preparing Annual Product Review (APR) and its review and approval.

• Consummate professional with demonstrated capability in ensuring judicious utilization and allocation of available resources - materials, machines and manpower, to achieve organizational targets; excellent ability to interact with different people simultaneously under difficult situations, with the aim of bringing out the best in them while creating a healthy and friendly work environment and thereby enhancing operational efficiency.

• Handled Regulatory requirements and Dossiers filling in various countries of SEA, AFRICA, LATAM for formulation at ACTD, CTD modules. SMF preparation and Guidance on Dossiers modules for various countries on requirement basis including eCTD.

• Execution of Regulatory requirements for various International Agencies and Independent communication with the key opinion leaders in the Department. Management and control on SOP’s for International Site Inspection objective.

• Strong background in enforcing budgetary controls and implementing cost rationalization measures to achieve projects implementation within agreed time/cost parameters.

• Computer savvy with hands on knowledge of SAP, MS-Office – successfully implemented QA Module & Production Module.

Career Milestones

• Successful association with Ranbaxy Laboratories Ltd for more than 16 years and executed diverse responsibilities including , Quality Assurance, Regulatory Compliance Audits including US FDA, TGA, WHO GMP, EU, Safety Initiatives, DMF Filling, Dossier preparation and Resource Management

• Appreciated for outstanding performance and rewarded Individual Excellence Award in Ranbaxy Laboratories for improving the quality, cost savings, inventory liquidation and reducing cycle time in 2006.

• Conducted Self-Auditing of Manufacturing / Production Areas, QC Lab to ensure GMP/GLP compliance.

• Handled and reviewed deviations, online rejections, change controls, OOS and OOTs , BPRs , SOPs , VMP and validation protocols

Professional Experience and Accomplishments

General Manager (QA & Regulatory Affairs)

Ratchet Laboratories Ltd., Baddi, Sep 2009 to till date

Ratchet Laboratories Ltd is engaged in manufacturing of pharmaceutical formulation and is the supplier of more than 300 products with approximately 100 formulations in the form of Liquid, Ointments, Tablets, Capsules, Dry syrup, Dry powder injections, Liquid injections, eye & ear drops, etc. The company has GMP approved manufacturing facility located at Bagbania, Baddi- Nalagarh Road, Baddi, Solan, (Himachal Pradesh). The Corporate Office of Ratchet Laboratories is located at IT Park, Chandigarh.

• Entrusted with overall responsibility to supervise the QA activities, implementation of QA systems, managing regulatory activities in accordance with internal and external regulatory requirements and driving process of relevant certifications with regulatory authorities.

• Actively involved in steering and building an organizational culture as a Catalyst where quality is an integral part of the business.

• Demonstrating excellent people management capabilities and engaging people to raise awareness of uses, hazards, and regulatory responsibilities.

• Successfully leading the Quality & Regulatory Affairs function aligned with the company strategies, policies & plans; securing approvals according to regulatory plan.

• Involved in online audit of plant, internal audit & GMP training to the team members.

• Competently improving administration and resolving issues commonly encountered during customer queries, customer complaints and Product recalls.

• Managed the entire spectrum QA functions and implementation of QA systems.

• Involved in managing regulatory activities as per internal & external regulatory requirements.

• Played an active role in managing the processes for relevant certifications with regulatory authorities.

• Supervised the Quality & Regulatory affairs function in line with company strategies, policies and plans.

• Responsible for local compliance with internal and external standards as well as GMP, vigilance and quality system training programs.

Sr Manager / DGM (QA & Regulatory Affairs)

Ultratech Pharmaceuticals Ltd., April 2008 – Sept 2009

An innovative pharmaceutical company that manufactures and markets a broad range of healthcare products. The group’s operations range from formulations, animal health products and cosmeceuticals. The state-of-art-manufacturing facility is situated in Excise Free Zone-Barotiwala, Dist-Solan (Himachal Pradesh) India.

• Managed the entire spectrum QA functions and implementation of QA systems.

• Involved in online audit of plant, internal audits and manage regulatory activities as per internal & external regulatory requirements.

• Played an active role in managing the processes for relevant certifications with regulatory authorities.

• Supervised the Quality & Regulatory affairs function in line with company strategies, policies and plans.

• Responsible for local compliance with internal and external standards as well as GMP, vigilance and quality system training programs.

• Actively involved in executing a wide array of activities ranging from developing improvement plans for filling sites, regulatory evaluation & documentation, customer complaints, pharmacovigilance system, and clinical trials involved in any new projects.

• Successfully managed regulatory activities and steered the processes for certifications with regulatory authorities.

• Established processes for medical quality, focusing on sustaining and maintaining improvements.

Senior Executive / Manager

Ranbaxy Laboratories Ltd., Oct 1992 – April 2008

• Involved in managing the quality assurance, regulatory affairs, documentation, operations and planning activities along with a team of 90 Members.

• Prepared reports on activities & procedures and ensured adherence to US FDA, TGA, and WHO-GMP, EU regulations and internal, external & safety audit.

• Involved in maintaining records as per GMP requirements; conducted Faced Audit of US FDA, TGA, WHO GMP, EU, safety and self-auditing of manufacturing / production areas, QC Lab to ensure GMP/GLP compliance .

• Ensured adherence to various SOPs, STPs & SCPs; handled & reviewed deviations, change controls, OOS & OOTs.

• Reviewed & implemented request of MPR initiation.

• Monitored & updated Validation Master Plan (VMP) by identifying various areas and requirements for validation.

• Actively involved in the erection & commissioning of formulation Plant

• Facilitated continuous improvement of critical business processes on meeting the business /functional/departmental objectives.

• Managed the Production Planning & Control Activities, installation of plant machinery, setting up production targets and handling plant operations to ensure timely completion of production targets within the defined time and cost parameters.

• Played an important role in effective resource planning & utilization, reducing wastes for enhancing productivity and profitability.

• Participated in failure investigation (out of specification) and conducted root cause analysis.

• Ensured regulatory FDA audits for different organizations with different capacities.

• Accountable for Materials Management, developing alternate vendor source in coordination with purchase department for achieving cost effective purchases of apparatus & chemicals, sophisticated instruments within shortest delivery time.

• Mentored, motivated and guided the team members by identifying core competencies and defining a career growth path.

Academic and Professional Credentials

MBA - Production & Operation Management

NIM, Mumbai

Diploma in Pharmaceuticals

Institute of Chemists, Kolkata

MSc. (Chemistry)

Vinayaka Mission University, Salem

Bachelor of Science (B.Sc.)

Punjab University, Chandigarh

Audits Handled

• US FDA - 1993,1996,1998,2000,2003,2007,2008

• Therapeutics Group Administration (TGA – Australia) - 1997,2000,2004

• Germany Audits - 2005,2007

• WHO – GMP Audits - 1999,2003,2007,2008,2009,2010

Trainings / Courses Attended

• Implementation of SAP (Production & QA Module)

• Budget exercise activities

• cGMP Training programme

• First aid & other safety related programme

• Enterprises Resource planning (ERP)

• Quality Management

• Validation & qualifications

• Business Excellence

Computer Proficiency

SAP, MS Office and Internet

Personal Details

Address : H.No – 593, Phase XI, Mohali 160065

Date of Birth : 29th Jan 1971

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