Salary : INR 6,00,000 - 10,00,000 P.A. best in industry
Job Description:
CORE KNOWLEDGE AND RESPONSIBILITIES FOR TECHNICAL MANAGER - AR&D
Planning and execution of all AR&D projects as per timelines
Team management & monitoring
Responsible for efficiency improvement and up gradation of AR&D processes
Knowledge on dossier requirements of different markets / formulations
Having adequate knowledge in current GLP requirement & all analytical instruments and like HPLC, UPLC, GC, Dissolution tester and UV-Visible spectrophotometer and etc.
Having technical exposure on testing of in-process and finished product batches such as Assay, Related substances/compounds, Dissolution, Content Uniformity & etc as per GDP.
Experience in Method validations, Method Verifications and Method Transfer for analytical methods of drug products such as Assay, Content Uniformity and residual solvents by using HPLC, GC and UV-Visible spectrophotometer as per current ICH guidelines and Pharmacopoeia.
Having adequate knowledge in Preparation and review of analytical method validation/ method verification protocols, Method transfer/Routine/Stability documents for drug products such as Assay,
Having adequate knowledge for the review of analytical raw data & trend of stability samples.
Ability to work in a multi-task environment & produce high quality outputs.
CORE KNOWLEDGE AND RESPONSIBILITIES FOR AR&D MANAGER - QA
Responsible for Implementation, continuous monitoring and reviewing of Quality management system.
Responsible for obtaining of updated regulatory information and implementation in laboratory.
Responsible for Validation master plan and Qualification of equipments
Reviewing and approving of tech transfer documents / PDRs
Knowledge on analytical method development and method validation activities of different formulations.
Overall implementation and monitoring QMS activities of AR&D department.
Responsible for reporting of deviations to management and conducting of management review meetings.
Responsible for conducting of internal audits and Quality checks.
Responsible for handling of customer complaints and investigation.
Responsible for implementing Quality system procedures and revision of existing procedures as per regulatory requirements.
Responsible for quality system documents management.
Handling of non conformity activities and timely reporting to customer.
Responsible for addressing customer queries and preparation of CAPA reports.
Responsible for work allocation & monitoring of regular activities.
Preparation and review of Site Master Laboratory Information file.
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