Job Description

Education & Experience: M.Sc. or Higher Qualification in Analytical/Organic Chemistry / Pharmaceutical Chemistry. Min. 8 -10 years Experience in a Quality Control/Analysis laboratory in a cGMP/ISO environment, with exposure to method development and validation activities. Technical skills & Competencies / Language Technical competence. Leadership skills. Analytical ability. Planning ability. Communication skills. Problem solving. Team building. KEY ACCOUNTABILITIES Co-ordinating and ensuring appropriate and timely analytical activities such as: Analysis and approval Establishing quality and HSE systems in the laboratory Sampling, analysis and approval / rejection of raw materials, packaging material for process samples, intermediates and finished products Preparation of sampling plans and allocation of work Coordinating with Production, Warehouse and QA for Approval / Rejection of RM, PM, intermediates and finished product Development, validation and verification of relevant analytical methods Coordinating with external laboratories regarding analysis of samples Investigating OOS results and deviation in a timely manner and implement the proposed corrective actions and to plan effective preventive actions for the improvement in the quality system Managing retained samples Maintaining adequate inventory of chemicals, reagents and reference standards Analysis, monitoring and managing of stability samples Investigating customer complaints Disposal of laboratory waste according to the established procedures Development of labels for the API s and intermediates Preparation of CAPEX requirements for Analytics Implementing the applicable Sops in the laboratories Develop tools for harmonized functioning of the laboratory Review of analytical data and approval/Re of raw materials, In-process samples packaging material, Review of analytical data for intermediates, and API for Chemistry Ankleshwar Release /Rejection of RM and PM Documentation Generation, managing and archiving of documents in laboratories as per requirements. Regular review and approval of the SOP s, specifications, formats, labels and other relevant documents. Evaluating technical agreements. Issuance of analytical data. Regulatory and other Compliance Compliance to current GMP guidelines Compliance to local and international HSE norms Regulatory compliance Regular Pharmacopoeia and regulatory requirement review for compliance To participate in any regulatory/Customer/other inspection that takes place at the site Training of self and subordinates on quality and HSE systems Vendor audit To conduct Third parties audits as per company requirement. Other projects Trouble shooting activities. Participation in projects. Discharging QA responsibilities in absence of QA personnel. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations

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