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Monday, December 13, 2010

VP Corporate Quality Assurance, Quality Control & Regulatory, Mumbai

Summary

Experience:
15 - 25 Years
Location:
Mumbai
Education:
UG - Any Graduate - Any SpecializationPG - M.Sc - Bio-Chemistry, Chemistry
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Head/VP/GM-QA/QC
Functional Area:
Production, Maintenance, Quality

Desired Candidate Profile

Origin Consultants Pvt Ltd an Executive Search Services Company has been retained by aLeading Manufacturer Of Active Pharmaceutical Ingredients And Pharma Intermediates to identify Vice President – Corporate QA, QC & Regulatory to be based at Dombivili, Mumbai

~ M.Sc / Ph.D (Analytical Chemistry) with Specialization in Regulatory Affairs

~ 15 to 25 years of experience in QA, QC and Regulatory, Analysis and interpretation of results cGMP and GLP.

~ At least 15 years of experience in leading a team of professionals in QA, QC & Regulatory

~ Knowledge of Production Processes, ISO 9000/14001, in API industry only

~ In-depth / broad-based knowledge of advanced QA, QC, Regulatory, cGMP, GLP

~ Experience of filing DMF and handling Audits (like USFDA, EDQM, Customer Audits)

~ Experience in analysis and interpretation of results

~ Knowledge of Production Processes

~ Sound knowledge of Systems

~ Proven strategic and conceptual capabilities that can be applied to the development and improvement of systems

~ A pro-active, energetic and motivating leader who can analyse and advise on QA, QC, Regulatory Affairs outcomes independent of pressures

~ Capable to coordinate effectively with R&D, Operations and Corporate functions

~ The leadership skills to work with and motivate diverse groups of people, both within and outside to achieve agreed goals

~ Versatility in understanding and interpreting pharmaceutical issues, trends and implications in the Quality, cGMP and Regulatory areas, (e.g. electronics records, quality systems approach, risk management, system-based inspections, etc.)

~ Capability to promote Quality and Compliance, able to motivate sites and units to continuous levels of quality excellence and regulatory awareness

~ Strong interpersonal, verbal and written communication skills

~ High on Integrity and Personal Value systems

~ Socially Confident

~ Good Peer relationships/ Management skills.

~ Should have strong Analytical Skills

~ Should have handled Quality Assurance, Quality Control and Regulatory functions independently

~ Hard working, positive attitude, excellent communication skills, willingness to learn, strong presence of mind

Mail your profile in word format to originconsultants @ gmail.com
For inclusion in our knowledge base & to keep abreast of Career Opportunities That Match Your Profile Connect to Nita Thaker on Linkedin - www.linkedin.com/in/nitathaker
TO DISCUSS YOUR PROFILE CALL: Nita Thaker, Head Executive Search on +91-22-28261800 / +91-22-28268407

Job Description

Executive Search for a Leading Manufacturer Of Active Pharmaceutical Ingredients And Pharma Intermediates to identify Vice President – Corporate QA, QC & Regulatory to be based atDombivili, Mumbai


The position of the Vice President – Corporate QA, QC & Regulatory is based at Dombivili and reports to the Chairman & Managing Director


As a Vice President – Corporate QA, QC & Regulatory your responsibilities include the following


~ Lead a team and head the overall Q.A department for regulated & non-regulated markets for API's & Formulations, face international quality audits and get major approvals for the Company

~ Oversee the quality assurance operations and services and ensure compliance to Current Good Manufacturing Practices (cGMP)/ USFDA and other regulatory requirements.

~ Responsible for setting up & managing the function effectively for Preparation, review & submission of ANDA's / NDA Dossiers to Regulatory Agency (USFDA)

~ Conduct product and process quality checks following established work instructions and sampling plans, and ensure that all products and processes meet the standards, Customer quality requirements, and regulatory requirements and regulatory requisites.

~ Provide expertise on product and process quality and compliance issues.

~ Provide interpretation of cGMP, general compliance and quality systems requirements

~ Assess compliance to cGMP and quality systems across the area of accountability and provide expertise and support for corrective actions, improvement and readiness for inspections.

~ Foster advanced QA and QC methodologies to improve quality and compliance while simplifying processes to promote a quality-based, cost conscious, continuously improving and self challenging

~ Lead international / domestic customers as well as Regulatory inspections / audits.

~ Maintain QC documentation to current standards & needs.

~ Provide required QC inputs or regulatory filings with international regulatory agencies

~ Manage, coach and develop QC and Compliance professionals within the Quality and Compliance unit and contribute to the growth

~ Compilation and filing of controlled correspondences & bio correspondences with US FDA

~ Stability protocols , Stability data, COAs, Process validation protocols and process validation reports etc.

~ Give directions and monitor the Quality activities of the manufacturing operations Centers of Excellence

~ Assess industry trends across all areas of cGMP and anticipate the needs of both the company and the customers and communicate these trends and appropriate options for the company to pursue.

~ Represent the company in international quality and regulatory compliance organizations and agencies (such as the FDA, EMEA, etc.).

~ Proactively monitor sources of trends, complaints, failures, deviations and changes to identify opportunities for system, process and product improvements.

~ Work in a complex diverse and international environment to obtain solutions based on a solid background and understanding of the pharmaceutical industry.
Keywords: QA, QC, Regulatory, Quality Assurance, Quality Control, Regulatory Affairs, Current Good Manufacturing Practices, cGMP, USFDA, EDQM, Customer Audits, Process validation, Production Processes

Company Profile

Origin Consultants Pvt Ltd an Executive Search Services Company has been retained by a Leading Manufacturer Of Active Pharmaceutical Ingredients And Pharma Intermediates to identify Vice President – Corporate QA, QC & Regulatory to be based at Dombivili, Mumbai

The Company is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and Pharma Intermediates. The company with a turnover of over Rs 500 Cr employs 700 dedicated professionals and R&D scientists across 3 manufacturing facilities in Maharashtra all within 150 kilometers from Mumbai. The Manufacturing facilities are complaint to USFDA, WHOEDQM and GMP global regulatory standards in addition to being ISO 9001:2000 & ISO 14001:2004 certified. The Company has won the IDMA Quality Excellence Silver Award in the category of Bulk Drug Units and is an US FDA inspected Active Pharma Ingredient manufacturer with excellent custom synthesis capabilities. 

The Company has a 200 strong in house Research & Development (R&D) team comprising of Research Scientists (including 50 Doctorates / PhDs), Analytical Development Scientists and 20 members in the Kilo Lab team. The company offers APIs and Custom Syntheses Services meeting International quality standards and aspires to be one of the top 3 producers of APIs in the world. 

Growing at an annual rate of 30% YOY, the company has made its presence felt worldwide and boasts of a customer base across USA, Europe, South Africa and Asia. The company has a culture which values business ethics, integrity & transparency and is looking for a Vice President – Corporate QA, QC & Regulatory 

ORIGIN CONSULTANTS PVT LTD

Origin Consultants Private Limited is an Executive Search Company, which partners with Professional Organizations in a Human Resource Consulting Process aimed at Talent Acquisition, Recruitment and Selection of Organizational Leaders.

Headquartered in Mumbai, India, Origin Consultants Pvt Ltd focuses on Senior and Middle Management positions across Industries, Functions and Roles. Origin Consultants has established delivery teams and technology infrastructure at Pune, Bangalore, Chennai, Hyderabad and New Delhi.

With a Strong Network of Professionally Qualified and Experienced Candidates, Origin Consultants have conducted numerous successful Executive Searches for their Clients. Customers of Origin Consultants range from Startups to established Fortune 500 Clients and From the Largest Indian Corporations to Global MNC Multinationals.

Connect with Origin Consultants Pvt Ltd on Linkedin
Contact Details
Company Name:
Origin Consultants Pvt Ltd
Executive Name:
Nita Thaker, Head Executive Search
Address:
Not Mentioned
Telephone:
91-22-28261800
Reference ID:
VP Corporate Quality Assurance, Quality Control & Regulatory, Mumbai

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