About the company
About the Job
Location: Ahmedabad
Experience: 15 - 20 years with a minimum of 8-10 years in managing the GMP lab
Job Role:
To lead a group and take part in logical procedures for strategy approval, move and other GMP business related to perplexing, separated, 505b (2) and nonexclusive ANDAs, inside subject matters to address explicit specialized necessities of an undertaking/program
Oversee asset arranging (lab too labor) and guarantee the accessibility according to necessities sooner rather than later.
Prioritization of tasks in light of apportioned yearly financial plan and assets
Assess results comparative with item prerequisites, definitions and additionally program objectives.
Assemble compelling relationship with CFT/CMOs/CROs and different clients
Play a lead job in goal of the difficulties looked during approval and strategy move of new items from Research and development to various Assembling destinations
Liable for recognizable proof and acquirement of required CAPEX (instrument/gear) in scientific improvement division for item advancement
Give arrangements and additionally propose on strategy approval/move/examination/PP concentrates on related difficulties
Survey plan, coordinate and oversee lab exercises collaborating with colleagues
Audit project spending plan and timetable, recommendations by teaming up with other partners
Adherence to the Baxter's Governing set of rules standards, SOP consistence relating to improvement, quality, and Research and development site
Play a lead job in help to assembling site during review
Liable for all remediation related exercises
Guarantee the PDLM cycles and execute being developed program according to GQP necessities
To help the administrative for recording and question reactions
To guarantee convenient conclusion of value components (CCN/CAPA/NCR/SNCR)
Keep up with center around meeting both outer and inside client assumptions
Peruse and see all phases of preparation/SOP's relevant to Research and development and guarantee to follow the cycles/Practices according to characterized SOP's by colleagues
Support the board in closing Quality reviews, GMP lacks reaction
Should agree with wellbeing strategies of the organization and site
Gives direct training, coaching and advancement to every individual from the group, both in execution of their obligations and in their very own turn of events
To guarantee consistence/moderation of Danger, E&C, Information respectability, preparing and GLP in ADL division
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QA Openings in Cohance:
Greetings for the day!!!
Cohance is hiring officers/Executives in Quality Assurance department for the Formulation unit (OSD), Nacharam, Hyderabad.
Those who have experience in IPQA, AQA are required.
Interested and suitable candidates can email your resume to [email protected]