Lab Lead

Company DescriptionEurofins Advinus is a premier preclinical and early development CRO offering drug discovery preclinical and development stage contract research services in the areas of discovery services regulatory Toxicology Safety Assessment DMPK Analytical R D Services and API CDMO Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies With over 30 years of GLP compliance and certification Eurofins Advinus serves diverse industries such as Biotech Pharmaceutical Biological Agrochemical Nutraceutical and Cosmetic Eurofins Advinus is the only contract research organization CRO in India to have developed data in support of 90 end-to-end IND enabling packages to be submitted to global regulators such as USFDA EMA MHRA Health Canada and others Job description Must be 15-20 year of experience should be handles a team of 20-30 peoples Job description Responsible for following the cGMP GLP Safety norms and adhere to company s policy Responsible for managing the Laboratory Operations Planning troubleshooting technical issues related to Method Development Validations of various techniques used in Pharma testing Responsible for the Day-to-Day activities of the lab GLP GMP adherence to best practices guidance to team customer relationship attending escalation meetings maintaining the lab related data project status Issue resolution etc Responsible for the review of key Analytical documents generated during the analysis ensuring the quality of documents in terms of scientific content interpretation observations final conclusion etc are upto mark meeting the regulatory standards Responsible for the approval of technical and quality related procedures and results reports Responsible for capability feasibility confirmation for the enquiries from Business development team and customers with respect to all the service offerings of BPT Working closely with BD team on providing quotes and addressing any follow up queries Responsible for the Qualification of new instruments equipment Should ensure use of instruments equipment s meeting established performance specification and are properly calibrated and maintained Should ensure training of the team members in order to execute the assigned responsibilities right first time adhering the Sop s and compliance requirement Should follow GDP for documentation and ALCOA principals on data integrity Responsible for the prompt investigation of abnormal observations of OOS Deviation Laboratory errors instrument malfunctioning etc or obvious error occurred during the analysis in coordination with Group Leader and Quality Assurance Should be responsible for initiating and completing the activities related to change controls as per the SOP Responsible for participating actively in Audits as a representative for analytical team and to provide CAPA for the observations if any within the stipulated time Skills Required 17-18 years in Quality Control Analytical R D of Drug Substances Drug Product manufacturing company or in CRO environment Excellent technical problem-solving writing influencing people leadership and communication skills Willingness to adapt to rapidly changing scientific and regulatory environments Experience in troubleshooting of the instruments like LCMS GCMS ICPMS XRD PSD HPLC GC Dissolution etc Prior experience in facing regulatory audits like USFDA EMA etc is must Knowledge of regulatory strategies or filing of NDA ANDA s DMF etc so as to understand the client needs and expectations QualificationsM Sc - Analytical Chemistry Organic Chemistry General Chemistry Industrial Chemistry