Quality Management

KAMANA SINGH

BVSc MVSc MMB RAC (US) MBA

302-***-**** 3490 Pin Oak Lane, Chalfont, Pennsylvania 18914 ******.*****@*****.***

US Regulatory Affairs Certified Professional with successful experience in regulatory affairs, quality assurance

and new product development in biotechnology, pharmaceutical and chemical industries. Adept in evaluating,

interpreting and analyzing scientific data applicable to solving scientific issues. Collaborates effectively with cross

functional teams; excellent communication skills and adept in prioritizing tasks in a changing and dynamic

environment.

Knowledge and experience in:

Compliance with regulations and ethical guidelines such as cGMP (Good Manufacturing Practices), GCP (Good

Clinical Practices) and GLP (Good Laboratory Practices) as applied to the drug development process

worldwide.

Efficient working knowledge of Quality Management System as required by regulatory bodies.

Working with cross functional teams for regulatory submission and registration requirements.

Working knowledge of entering, managing and analyzing quality and regulatory data in the electronic database

systems like Documentum and Intlex.

Quality processes improvement by CAPA development and management

Reviewing and managing Change Control system as required.

Resolving quality issues using Root Cause Analysis and Risk assessment and management using Failure

Mode and Effects Analysis.

Organizing meetings as needed and maintaining records of meeting minutes and t raining other team

members on various quality and compliance related requirements.

PROFESSIONAL EXPERIENCE

2010 – 2011

STRATEGIC DIAGNOSTICS, Newark DE

Manufacturing Quality Engineer

Provided quality management support to the Product Development Core Team . Ensured all developed and

marketed products complied with quality requirements.

Served as a member of Senior Leadership Team and collaborated with R&D, Marketing, Operations and

Quality Assurance groups to develop and implement appropriate quality management, qualification,

verification and validation.

Established appropriate release tests based on customer applications ; served as customer liaison to

resolve quality issues.

Interacted with vendors and sub-contractors for negotiating specifications on raw materials purchased for

product development.

Developed and implemented company’s policies and procedures to establish tools and techniques for

quality evaluation.

Coordinated manufacturing validation and post commercial launch activities .

Monitored quality control testing program, including stability testing program and lot-to-lot variability.

Led problem-solving efforts to identify and resolve new and recurring quality issues using Root Cause

Analysis.

Developed, implemented, managed and tracked effectiveness of Corrective Action Plans and Compliance

improvement (CAPA) initiatives.

Fostered continuous quality improvement by proactively reducing variation and eliminating defects.

Maintained and communicated accurate project schedules are to both internal and external management.

2009 – 2010

CRITICAL PATH SERVICES LLC, Garnet Valley, PA

Global Registration Coordinator

Global Registration and Regulatory Affairs Department, DuPont Crop Protection, Newark, DE

Prepared dossier to fulfill the requirements for registration of products in different countries based on country-

specific regulatory requirements. Prepared documents for electronic submissions to the regulatory bodies

worldwide.

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KAMANA SINGH

Planned effective registration strategies for various products in collaboration with the Global Registration

Managers.

Addressed issues raised by regulators worldwide regarding registration or approval of Dupont Crop

Protection products and prepared timely, accurate responses to their concerns and questions.

Managed database that housed hundreds of documents.

ADHEREX TECHNOLOGIES, INC. Durham, NC 2008

Regulatory Affairs Consultant

Oversaw submission and review of regulatory documents, such as IND safety reports, clinical study reports and

protocol amendments to the FDA.

Developed new Standard Operating Procedures (SOPs) related to clinical trial studies.

Preparation of scientific rationale for conducting clinical trial of a potential drug cand idate.

2007 – 2009

INDUSTRIAL INTERNSHIPS

Piedmont Biofuels, Pittsboro, NC (Jan 2009-May 2009)

W orked as consultant for a project to improve the efficiency of the plant producing biodiesel.

Created feasibility studies for alternative techniques for dealing with wash water and glycerine, sidestream

products of biodiesel production.

Assisted in performing an energy balance study on the Piedmont Biofuels Industrial plant for all of its

processes relating to biodiesel production as well as alternative pr ocess.

Biolex Therapeutics, Inc. Pittsboro, NC (Jan 2008-May 2008)

Developed efficient methods of energy conservation and waste management.

Educated and trained 20-25 professionals in the company directly involved with the manufacturing of

product to promote awareness of the importance of making the environment cleaner in a project called

‘Operation Green Frond.”

Biogen Idec, Research Triangle Park, NC (Aug 2007-Dec 2007)

Performed a microbial risk assessment using tools, such as Failure Modes and Effects Analysis.

Evaluated current practices related to Quality Control in the manufacturing facility and detailed

assessment of SOPs. Reviewed SOPs and suggested modifications for better assessment of microbial

contamination in manufacturing area.

EDUCATION / CERTIFICATION

UNITED BUSINESS INTITUTE, BRUSSELS, BELGIUM 2014

Masters in Business Administration-Major: Project Management

NORTH CAROLINA STATE UNIVERSITY, Raleigh, USA 2009

Professional Science Masters / Masters in Microbial Biotechnology (PSM/MMB)

REGULATORY AFFAIRS PROFESSIONAL SOCIETY (RAPS) CERTIFICATION BOARD 2008

US Regulatory Affairs Certified (US-RAC) 2011 & 2014(Recertified)

NATIONAL DAIRY RESEARCH INSTITUTE (NDRI), Karnal, India 2004

Masters of Veterinary Science (MVSc), Major: Animal Biotechnology

G.B. PANT UNIVERSITY OF AGRICULTURE & TECHNOLOGY, Pantnagar, India 2002

Bachelor of Veterinary Science (BVSc; DVM equivalent)

PROFESSIONAL DEVELOPMENT

The Future of Healthcare: A Prognosis for 2015, Teva Pharmaceuticals, Horsham, PA, Feb 2015

Biosimilars and Biobetters: Regional Biotech Council Annual Conference, Doylestown, PA, Oct 2014

Guide to Doing Business around the World, Healthcare Businesswoman’s Association, Collegeville PA, March

2013

Adopting a Pragmatic Approach to Compliance (webcast), Oct 2012

Medical Device Summit Supplier Controls and Quality Management Conference, Washington DC, Jan 2011

Advances in Label-Free Assays for Antibody Discovery, Development, Characterization, and Bioprocessing (webinar),

Dec 2010

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KAMANA SINGH

RAPS Annual Conference and Exhibition, Pennsylvania Convention Center, PA, Sept 2009

Course in Regulatory Compliance, GlaxoSmithKline, RTP, NC, March 2009

RAPS Webcasts on US regulatory affairs (Contents: Regulatory pathways/Regulatory Options, Testing

Requirements/Compliance, Submission, Listing, Registration and Obtaining Approval, Documentation and

SOPs), Aug 2008

Advertising, Promotion and Labeling, Postmarketing Surveillance/Vigilance, Aug 2008

Distribution, Postmarketing/Maintenance, Crisis Management, Interfacing with Regulatory Agencies, I nspection,

Government and Public Relations), Aug 2008

North Carolina regulatory affairs form (NCRAF) sponsored course on ‘Introduction to US Regulatory Affairs

Course, Oct 2008

NCRAF sponsored course: Introduction to Canadian Regulatory Affairs, Mar 2008

NCRAF sponsored course: Introduction to European Regulatory Affairs, Jan 2008

Council of Entrepreneurial Development (CED) Biotech 2007 Conference, Durham, NC, May 2007

ACADEMIC EXPERIENCE

2006 – 2009

NORTH CAROLINA STATE UNIVERSITY, Raleigh, NC

Teaching Assistant, Department of Biological Sciences (2007-2009)

Research Assistant, Molecular Biomedical Sciences (2006-2007)

2005 – 2006

UNIVERSITY OF MISSOURI-COLUMBIA, MO

Research Assistant, Department of Veterinary Pathobiology

PROFESSIONAL MEMBERSHIP

Member, Regulatory Affairs Professional Society (RAPS)

Member, American Society for Quality (ASQ)

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