Lab lead /Associate Director

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.