Role & responsibilities Managing the projects/ studies for timely start and completion of the projects in conformance to GLP guidelines. 2. Allocate personnel for conducting bio analytical study and maintain list of persons to whom trial related activities are delegated. 3. Ensure that the study personnel are qualifies by appropriate education, training and experience to accept the responsibility for the delegated study related activities. 4. Method Development and Method Validation, executing methods for analysis of drugs using Solid Phase extraction, Liquid-Liquid extraction and Precipitation techniques for BA/BE studies are as per applicable regulatory requirements. 5. Ensure compliance to GLP and safety in Lab, Assessment and training of staff on GLP and SOPs and applicable regulatory guidelines. Implementation of Standard Operating Procedure for the analytical method developed and general procedures. Ensure that all relevant SOPs are available in work place. Ensure routine maintenance and calibrations of all the equipments used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Ensure computerized systems used in the studies has been validated as per the regulatory requirement. Review and provide inputs for the documents like protocol, study reports, method validation reports, method SOP’s etc. and finalize the same in co-ordination with other departments. Review of the electronic generated data, raw data and logbooks to ensure validity and accuracy. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure. 12. Approve the individual sample repeats, ISR and investigation of batch failures. Preferred candidate profile candidate with relavent 2-5 year of experience is most.
Roles and Responsibilities Manage finance and accounts operations, including accounts payable, accounts receivable, TDS, taxation, and auditing. Oversee financial planning, budgeting, forecasting, and reporting to ensure accurate financial statements. Ensure compliance with accounting standards (AS) and internal controls to maintain transparency and integrity of financial data. Coordinate with external auditors for annual statutory audits and provide support during tax assessments. Maintain balance sheets by ensuring accuracy of bank reconciliations.
Role & responsibilities Plan, execute, and complete the method development and method validation, execute methods for the analysis of study samples within the committed timelines. 2. Supervision of sample processing and analysis for BA/BE studies as per applicable regulatory requirements. 3. Preparation and review of bioanalytical method validation reports, method SOPs and study reports. Ensure routine maintenance and calibrations of all the equipment’s used for various study in the department like LC-MS/MS, pH meter, analytical balance, microbalance, Centrifuge, Vibramax etc. Review of protocols, electronic generated data, raw data forms and logbooks, to ensure validity and accuracy. 6. Ensure timely archival of documents in both hard copy and soft copy formats. 7. Identification and compilation of the individual sample repeat, ISR and investigation of batch failure. To generate the result summaries and chromatograms. 8. For instrument troubleshoot and coordinate with the instrument engineers regarding the break down. 9. Assign and supervise projects for the research scientist and research associate and supervise all the activities in the assigned group and to train a newly joined team member. 10. Ensure compliance to GLP and safety in the bioanalytical laboratory. 11. To operate the instrument and to maintain the required consumables for equipment’s like LC-MS/MS. 12. Assist HOD during preparation audit responses for various regulatory bodies. Provide training for departmental personnel on SOP, current scientific and regulatory requirements. Ensure disposal of Bio-hazard materials or its contaminated materials as per the disposal procedure. Preferred candidate profile B Pharma / M Pharma OR M.sc in chemsitry or biochemistry with 2-7 years of expereince in bio-analytical deaprtment in any apporved CRO. Perks and benefits 5 Lacs to 12 Lacs