Our Hyderabad-based pharma Client started about 20 years ago as predominantly an API player, but, has, over years, morphed into a predominant formulations player; API-to-formulations changed 43%-to-57% in FY11 to 20%-to-80% now.  It operates 22 manufacturing facilities, including 8 formulations facilities in India and abroad; owns 3 R&D centres; current employee strength is - 8000, including - 750 scientists.  Company has been very aggressive in maintaining a very healthy pipeline of ANDAs; they have been able to pick right product mix to improve top & bottom line growth. The Organization is extremely dynamic and expects its leadership team in every function to measure up to this dynamism through their speed of response, quality and effectiveness of performance.   Client is hiring Corporate Quality Assurance professionals for their Formulations Business.   Purpose of the Job :   - Develop a transparent quality strategy and drive organization in its execution to ensure high quality, safe products and services compliant with regulatory expectations - Lead efforts for ensuring compliance with quality standards in every functional area of the Organization   Strategic Roles :   - Ensure that quality serves as a clear differentiator and a distinct advantage to Organization   Operational Roles :   - Design, develop and implement QMS applicable for QA, QC, qualification, validation and compliance activities   - Discuss, develop and deploy appropriate IT tools to improve overall operational efficiency   - Compliance with QMS   - Set goals for each functional area in the Unit on improving and sustaining compliance; as needed, scale up infrastructure to support business needs   - Ensure quality oversight of production units; warehouse (incoming quality & dispatch); engineering, review of calibration records, change controls   - Ensure batch manufacturing records and analytical records are reviewed for their completeness and compliance before release of product   - Ensure chemical & biological lab data is derived in accordance with systems and written procedures   - As needed support investigations into causes of deviations   Provide Quality Expertise :   - Approve specifications; standard test procedures; change controls; deviations; incidents; review and approve all validation protocols and reports; review and approve stability protocols and reports   - Review and approve risk analysis wherever required; use appropriate tools to make timely decisions to protect customers and Organization's image   - Demonstrate confidence during difficult decision-making and influence business partners to ensure acceptable quality outcomes   Continuous Improvement :   - Maintain positive relationships internally and externally while fostering a culture of continuous improvement across all functions in organization   - Develop appropriate metrics to monitor performance of products and/or services, quality system to drive continuous improvement   - Continually evaluate new technologies in order to improve operating efficiency, generate market differentiators and add sources of revenue   Customer Complaints :   - Ensure Product related complaints, product failures, deviations and Incidents are investigated, resolved as per laid down procedure in time   Team Management :   - Attract, retain and proactively develop a pipeline of key talent through coaching, training, experience development and internal/external recruitment   Preparing for Regulatory Compliance & Audits   - Develop and disseminate current and applicable regulatory expectations; trends   - Lead teams during inspections by Regulatory authorities and during customer audits   Training - Develop and impart training regarding QMS, Regulatory and/or other technical subjects

Hyderabad

Corporate Quality Assurance Professional - Formulations Business - Pharma 

Corporate Quality Assurance Professional - Formulations Business - Pharma  ,Job Description for Corporate Quality Assurance Professional - Formulations Business - Pharma  in TMI Network in  Hyderabad for (15-20) years of experience. Apply Now!

Job Description for Corporate Quality Assurance Professional - Formulations Business - Pharma  in TMI Network in  Hyderabad for (15-20) years of experience. Apply Now!