Indore

Gufic Biosciences Ltd is a leading pharmaceutical industry since 1970 and is one of the world’s largest Lyophilization injectables & wide range of API products, at Navsari.

Looking for clinical Database Developer experience in eCRF build and edit checks build in Veeva studio; Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process. Providing support for the mapping and transformation of clinical data to CDISC SDTM standards. Work independently and accountable for study Data Management deliverables; Coordinate with Biostatistician, Clinical, Medical and local study team as applicable

FP / Stability / Analytical Instrumentation-HPLC, UV and Dissolution; Handling of LIMS, Empower software, HPLC Waters; IPQA Mfg. and Packing, Shop floor activities. Review of equipment audit trails / BMR, BPR review / line clearance. Handling of CAPA / EC and External Audits USFDA/MHRA/Germany

To achieve the sales objective for the Area of operation in order to meet the business targets for the area in a given time frame. To achieve the activity objective by ensuring the compliance to the field process in order to build an orientation towards activity process among the team.

Strong understanding of OSD manufacturing processes and knowledge of cGMP and relevant regulatory requirements. Candidate should have good exposure to QC instruments HPLC/ GC/ LCMS, Dissolution, UV Spectrophotometer/ KF/ Autotitrator / Malvern analysis and trouble shooting 

Responsible for guiding and coaching employees, monitoring their productivity, and overseeing regular equipment safety and maintenance. Responsible for performing batch execution in Sterile Injectable lines manufacturing and packaging.

Contribute to the development and implementation of new safety-related systems, processes, and procedures within the process. Support a performance-driven culture.

Candidates having hands-on experience in Analysis of Raw Material, Packaging Material, Finished Goods, Stability, Method Transfer and Laboratory Investigations. Should have sound knowledge of QMS like Deviations, Change Control, Vendor Management etc.

Technician, Operators for Ampoule and Vial Filling & Manufacturing. Lyo Operators, AM/HVAC Engineer, Fireman, Electrical and Instrumentation Engineer, Wireman, Refrigeration, EHS and ETP Officer and AM