Job Title

About the Company Laurus Labs is an Indian multinational pharmaceutical and biotechnology company headquartered in Hyderabad. Its focus areas include active pharmaceutical ingredients (APIs), generic formulations, custom synthesis (CDMO), biotechnology, veterinary APIs and agrochemicals. The company was founded in 2005 by Satyanarayana Chava. Laurus Labs has its ten manufacturing plants located at Visakhapatnam & Hyderabad. The manufacturing units have received one or more approvals from USFDA, WHO, NIP Hungary, KFDA, MHRA, TGA, and PMDA. The company operates through its subsidiaries in Europe and United States and also offers its services in contract research, clinical research and analytical research through its R&D centers. The R&D centres are based in Hyderabad, Visakhapatnam and United States. Business divisions The company has 4 business divisions, which are generic formulation (FDF), generic APIs, contract development and manufacturing (CDMO)-Synthesis, biotechnology and speciality chemicals. About the Role - To define the strategy for quality unit to meet the regulatory requirements and productivity. - Implementation and maintaining of ALCOA+ and data integrity in the Quality Control Department. - Working for the filing of USDMFs, each year 15 Drug substances. - Having the good knowledge on controlling the lab inventory. - Proper planning and utilization of Manpower. - Best Co-Ordination with QC Team for better quality output. - Planning and monitoring of QMS of the site for closure on time and provide the guidance for investigation of OOS, deviation and CAPA. - Meeting the company business requirements by supporting in the Quality control aspects. - Investigation and closure of market complaints, deviations, OOS in a timely manner. - Monitoring release / rejection of starting materials, packing materials, purified water, Intermediates and finished products and monitoring stability program. - Ensuring the compliance of the QC for 21 CFR part 11 requirements with respect to software control, procedural control and user management. - Periodic review and comprehensive analysis, trends (as applicable) for market complaints, OOS, deviations, incidents and CAPAs. - Coordination with cross functional team like production, Quality Assurance, stores, engineering and administration. - Evaluation and monitoring compliance for existing quality system for current regulatory updates. - To provide technical support as well as response to various customer queries. - Tracking of all audit points, suggestions, recommendations and non compliance and ensure that agreed CAPA’s are implemented effectively. - Ensuring implementation of pharmacopeial updates to comply the pharmacopeia requirement. - Providing the continuous training for the Quality control personnel as per the current requirements. - Good Knowledge on stability studies. - Evaluation and Maintaining of Reference standards and working standards for Pharmacopeial and non pharmacopeial products. - Handling of Regulatory deficiencies and provide the response on time. - Good Experience on handling of Negative pressure Isolators. Qualifications M.Sc (Analytical/ Organic)/Ph.D (Chemistry) Required Skills - 17-22 years of experience in API Quality Control Operations - Deep Knowledge and understanding in Regulatory Compliance and Managing Regulatory audits and Preparedness across the Unit.