Independent handling of assigned projects of sterile ophthalmic and non-sterile dermatological products for the regulated and non-regulated markets.
Close monitoring and review of analytical raw data generated for developmental, routine, stability analysis of lab-scale batches, method validation, and vendor qualification activities.
Technical evaluation of assigned projects including guiding team in all kinds of development and validation activities as per project requirements, troubleshooting, and helping the team for timely execution of the project as per committed target completion date.
Preparation and/or review of documents such as development approach paper, method development report, product specification and test procedures, method validation protocols and report, method transfer protocol and reports, SOP, formats, CoA preparation, etc.
Review and/or approve Formulation Development documents including stability protocols, Drug-Excipient compatibility study protocols, QTPP, and others as per project requirements.
Review and/or approve documents and provide technical support to Rabale and Kandla QC team during method transfer and/or validation whenever applicable.
Executeinstallation and qualification procedures for instruments and equipment and monitor calibration of all instruments and equipment as required.
Co-ordination with service engineers for instrument and equipment maintenance and troubleshooting.
Monitor audit trail of HPLC and other instrument software with periodic review of soft data and keep control of all required parameters.
Close interaction with Formulation Development department for project management, technical discussion, and work management of assigned projects.
Monitor and support GDP, GLP, internal and external audit, and compliance-related activities within the department to be in-line with QMS and USFDA requirements.
Impart project-specific and/or other related training to the department and within a team as necessary.
Execute and monitor the training of newly joined employees within the team involving preparation of training modules, job descriptions, review of assessment test papers, etc., and ensure successful training procedures as per time schedule.
Co-ordinate with supporting departments at H.O., R&D, Rabale, Kandla plant and vendor, customer, external lab, consultant, etc. as and when required.
Assess outside CRO for any analysis and monitor project-related activities.
Assess requirements for new instruments/equipment, prepare URS, obtain comparative data, and monitor installation and qualification procedures.
Must have strong communication, technical writing, and presentation skills.
Effective planning, quality execution, and organization of work are a must.
Prior exposure to audits like USFDA, EU, TGA preferred.
Any other duties as per organizational requirements.
Mumbai
Galentic Pharma (India) Pvt. Ltd