Harman Finochem Looking for Req Group Leader/senior Group Leader For apiadl with Leading Pharma at Ranchi Aurangabad, BR Full Time

Hi,

We are a leading Pharmaceutical company into manufacturing of API & OSD for Regulated markets.

Job Location – Shendra, Aurangabad.

Education – M.Sc. /M. Pharm

Designation – Group Leader/Senior Group leader (API-ADL)

Experience – 15-18 years of experience in analytical development.

We are currently hiring for API- ADL.

Job Description.

• Literature search for method development and resolution of quarries for API projects.
• Responsible for overall lifecycle management of ADL projects including method development for raw materials, in process, intermediates and finished drug substance, preparation of analytical technology and transfer of analytical methods QC.
• Develop method for finished product based on the QbD approach also develops innovative methods to reduce the time of analysis, wherever applicable.
• Guide and monitor the scientists to maintain proper documentation as well as interpretation of analytical data also smooth functioning of day to day lab activities.
• Responsible to ensure analysis of samples received from R&D on time.
• Preparation and review of SOPs and Monitor the instrument maintenance activity and ensure for minimum breakdown
• Effective coordination with cross functional teams like R&D, Quality control, quality assurance, regulatory affairs, production, human resources , engineering , EHS etc.
• Preparation of technical documents with minimum supervision.
• To maintain the stability tracking and execute the same as per requirements.
• Method development and validation for regulatory quarries and arrange responses as per requirements
• Monitor procurement related activities for laboratory related requirement and to take follow up for same
• Characterization, Qualification of working standards for APIs, impurities and intermediates and release the CoAs.
• Utilization and handling of Caliber QAMS, Caliber DMS, Nichelon CMS & SAP activities
• Staff development for current requirements and knowledge enhancements.

Competences (Desirable):

• Candidates should be M.Sc. /M. Pharm with 15-18 years of experience in analytical development. Minimum 5 years of supervisory (team handling) experience.
• Expertise in HPLC/GC method development.
• Exposure to LCMS MS, GCMS MS
• Exposure to XRD, Particle size
• Knowledge of ICH guidelines and other regulatory guidelines.

Interested candidates can share their profiles on [email protected]