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Vice President Corporate QA, QC and Regulatory

Mumbai, MH
Job Code:
  • Manufacturing & Production
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Job Details

Lead a team and head the overall Q.A department for regulated & non-regulated markets forAPI s & Formulations, face international quality audits and get major approvals for the CompanyOversee 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 ofANDA 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 requirementsAssess 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 challengingLead 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 agenciesManage, coach and develop QC and Compliance professionals within the Quality and Compliance unit and contribute to the growthCompilation and filing of controlled correspondences & bio correspondences with USFDAStability 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 ExcellenceAssess 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 theFDA, 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 ProfileM.Sc / Ph.D (Analytical Chemistry) with Specialization in Regulatory Affairs18 to 20 years of experience in QA, QC and Regulatory, Analysis and interpretation of results cGMP andGLP.At least 15 years of experience in leading a team of professionals in QA, QC & RegulatoryKnowledge of Production Processes, ISO9000/14001, in APIindustry onlyIn-depth / broad-based knowledge of advanced QA, QC, Regulatory, cGMP, GLPExperience of filingDMF and handling Audits (likeUSFDA, EDQM, Customer Audits)Experience in analysis and interpretation of resultsKnowledge of Production ProcessesSound knowledge of SystemsProven strategic and conceptual capabilities that can be applied to the development and improvement of systemsA pro-active, energetic and motivating leader who can analyse and advise on QA, QC, Regulatory Affairs outcomes independent of pressuresCapable to coordinate effectively with R&D, Operations and Corporate functionsThe leadership skills to work with and motivate diverse groups of people, both within and outside to achieve agreed goalsVersatility 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 awarenessStrong interpersonal, verbal and written communication skillsHigh on Integrity and Personal Value systemsSocially ConfidentGood Peer relationships/ Management skills.Should have strong Analytical SkillsShould have handled Quality Assurance, Quality Control and Regulatory functions independentlyHard working, positive attitude, excellent communication skills, willingness to learn, strong presence of mind
Degree: M.Sc. (Science) | Ph.D. (Doctorate)

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 18-20


Finance | Marketing/Brand/Product | Operations/Customer Care
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