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Vice President – Corporate QA, QC & Regulatory

15 days ago: Adzuna

Job Description



Job Description : Reports To : Chairman & Managing Director 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 Job Description 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 APIs & 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 ANDAs / 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. Desired Candidate Profile M.Sc / Ph.D (Analytical Chemistry) with Specialization in Regulatory Affairs 18 to 20 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 For inclusion in our knowledge base & to keep abreast of Career Opportunities that match your profile connect to To Discuss Your Profile Call: on 91-22-28261800 ABOUT ORIGIN CONSULTANTS PVT LTD 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 and . 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. Job Description :Reports To: Chairman & Managing DirectorOrigin 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 Pre Experience: 18-20 YearsJob Description : Reports To : Chairman & Managing Director 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 Job Description 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 APIs & Formulations, face international quality audits and get major approvals for the Company Oversee the quality assurance operations and services and...