About the job
ProductLife Group is looking for CMC Associate to join our team in India
ProductLife Group is looking for CMC Associate to join our team in India
As CMC Associate you will have the opportunity to assist with:
Prepare CMC regulatory documents within established timelines (Modules 2.3 & 3.2, IMPD, variations)
Analyze and / or write scientific reports from the raw data provided by the client.
Regulatory compliance: comparison of analytical procedures and / or manufacturing process between MA dossier and manufacturing site procedures.
Provide on-going support to the CMC Leader and to project teams to ensure that project objectives are met.
Assist in the preparation or update of Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs)
Bachelor’s degree in life Science/ Pharmacy related field
0-2 years of experience in CMC and/ or Quality Assurance in Pharmaceutical Industry
Knowledge of EU regulations for pharmaceuticals
Fluent in English (written &spoken)
Excellent attention to detail
Ability to work well within a team
Good time management skills
Ability to work to tight deadlines
Process oriented
Excellent communication skills