- Business Development Support and validation oversite for implementation, validations and system upgrades/modifications of the computer systems.- Develop/ final review and approval of protocol, plans, scripts, reports associated with the implementation and maintenance of all computerized systems/validations design and execution.-Provide Quality support to the evaluation of software applications and firmware associated with computerized systems and equipment used in laboratories, manufacturing facilities/utilities.- Lead implementation of quality systems policies, procedures and practices that pertain to IT compliance /computer systems validation and data integrity -Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the computer system validation (CSV) procedures and requirements.-Manage the administration of CSV and associated discrepancies for electronic GXP systems.- Lead CSV projects including inquiries from the Business process owners pertaining to the interpretation and their regulatory requirements for computer system validation.- Work Closely and collaborate with various business partners viz. external customers and vendors.- Provide updates on projects, timelines for completion, process metrics for CSV to business process owners and communicate risk based escalation issues wherever applicable.- Provide resolution for project deviations, errors and provide compliant oversite to software validation projects. - Provide oversite during risk, Part 11 and Annex 11 and regulatory assessments.- Review changes to the validated state of the business owner systems through the change control and participate in planning and implementing changes.- Conduct validation training with project team communicating deliverables, procedures and method of script execution.- Support inspection readiness activities for regulatory audits.

- Planning, development and Implementation of Quality Systems for QC Laboratory with respect to personnel, equipment, facilities and documentation.- To achieve business objectives / targets / KPI’s as agreed.- New Laboratory setup viz., handling CAPEX for purchasing, commissioning and qualifications of laboratory instruments and equipment’s, Manpower recruitment, Implementation of quality systems, with respect to equipment, personnel, facilities and documentation and Management of overall quality control activities to comply regulatory audits.- Monitors laboratory resources, identifies/reports resource gaps, and assists in recruiting, screening, procuring, and/or qualifying needed resources.- Works in collaboration with other departments to evaluate and recommend improvements to analytical methods associated with validation, specifications, transfer, or review activities.- Review and approval of protocols and reports associated with/for method transfer and processvalidation.- Handling of Projects through SAP, LIMS and QMS (Oracle).- Investigate and approve all laboratory investigations.- Preparation and Execution of Laboratory Internal Audit Program (Self Inspections).- Review of monthly reports and Quality metrics in each individual sections of QC department.- Provide leadership, management, evaluation and training to all laboratory employees and to ensurecGMP / GLP is followed in QC Laboratory with good documentation practices.- Execution and approval of method transfer, and exhibit launch products on commercial setup.- To list/assist the Risk assessment (Risk management) for the activities of Quality control laboratory.

- Ensure all finished product analysis, Raw material analysis and packaging material and its timely release with compliance.- Ensure all Test Procedures and Specifications of raw material and finished product for all the commercial and exhibit manufacturing.- Execution of development / Validation of Analytical methods in timely manner.- Execution of Engineering batch/Launch of new products submission.- Handling of OOS/Deviations/CAPA.- Planning and execution of method transfer prior to exhibit manufacturing.- Preparation and Execution of Laboratory Internal Audit Program (Self Inspections).- Ensure Protocols are prepared and Execution of f1 and f2 similarity factor for Bio-Waiver products during commercial launch products.- Planning and Execution of analysis and disposition of Exhibit batch mfg. / Launch.- Planning and execution of Process validation sample analysis as per approved Protocol.- Preparation / Review of Standard Operating Procedure / Guidelines.- Calibration / Performance Verification / Preventive Maintenance of Laboratory Instruments / equipment’s.- Handling of Projects through SAP, LIMS and QMS (Oracle).- Review of monthly reports and Quality metrics in each individual sections of QC department.- Ensure the Primary / secondary Reference standard are well maintained as per defined procedures.- Ensure training and qualification of the analysts.- Qualification of Laboratory Instruments/Equipment’s (IQ, OQ, PQ).- Monitoring and ensuring that GLP is followed in the Laboratory.- Analytical / Technical support to the analyst during the analysis and troubleshooting.- Preparation and Review of weekly and monthly reports for the section.- Ensuring that required reference standards, chemicals, columns, working standards, are available for new project assignment.- Method Transfer of Analytical Methods in Quality Control Laboratory.

- Preparation / Review / Control of Analytical Protocols / Equipment Validation Protocols / Process Validation Protocols for all the Pharmaceutical Products.- Initiation / Review of Stability Protocols for Accelerated, Ongoing and In-Use stability samples.- Handling of CAPA, Deviations, Change Control through Quality Management System (QMS).- Preparation / Review / Training of Standard Operating Procedure (SOP’s) and Guidelines.- Review / Execution of Analytical Method Development, Method Validation, Instruments / Equipment Validation, Stability study, Formulation Development Protocols.- Stability data compilation and Submission of stability studies data to the regulatory authorities.- Prepare, review and approval of SOPs, Specifications, STPs, GTPs, Qualification Protocols.- Execution of Qualification (IQ, OQ, PQ) of New Analytical Instruments / Equipment’s.- Preparation and Execution of Laboratory Internal Audit Program.- Monitoring and ensuring that GLP/GMP is followed in the Laboratory.

- Responsible for Planning and Execution of Finished products, (Tablets and Capsules) for different regulated markets.- Manage review and approval of SOPs, Specifications, STPs, GTPs, Qualification Protocols through LIMS.- Handling discriminatory dissolution profiles studies and dissolution profiles with Innovator Products.- Maintaining Qualification (IQ, OQ, PQ) of analytical Instruments / Equipment’s.- Monitoring and ensuring that GLP is followed in the Laboratory.- Preparation and Review of weekly and monthly reports for the section.- Submission of analytical reports and Analytical data for timely submission to Regulatory Affairs for further submissions.- Ensuring that required reference standards, chemicals, columns, working standards, are available for new project assignment.- Review and ensure availability of resource requirement for new product tech transfer and product execution.- Reviewing and releasing indents related to QC operations through SAP.