Indore

Quality Control openings for BPharm, MSc at Lupin; Knowledge of HPLC, GC and others routine instruments of QC.

Responsible for monitoring and ensuring quality of products and comply with cGMP standards. Monitoring of critical process parameters, line clearance before batch initiation, verification of RM and equipment. In process sampling for quality check like pH, moisture content, and reaction monitoring.

Candidate should have strong understanding of OSD manufacturing processes and knowledge of cGMP and relevant regulatory requirements. Monitoring critical process parameters during manufacturing. Candidate should have sound knowledge of QMS - Incidents, Change control, Deviations etc. Should be able to handle the team of 8-10 persons

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