Urgent Vacancy for Jr. Manager- QA/ Regulatory Affairs, Research Scientist- AR&D department at Hyderabad
WE ARE HIRING!
Open Position
QA (2-4yrs)
Position: Jr. Manager
Qualification: – M.Sc/ M.Pharmacy
Job Description:
Quality Assurance
- Responsible for preparation and review of Quality Assurance SOP’s.
- Responsible for preparation, review and updating of master documents like Site Master File, SOP Master list, Instrument Master list, Instrument calibration calendar.
- Responsible for review of IQ/OQ/PQ documents of Equipment / Instrument.
- Responsible for review and approval of analytical method validation / method verification / method transfer protocols and reports with respect to adequacy.
- Responsible for monitoring of compliance with the cGMP requirements.
- Responsible for training and implementation of quality systems.
- Responsible for review of analytical documents.
- Responsible for conducting Internal audits.
AR&D (2-4 yrs)
Position: Research Scientist
Qualification: – M.Sc/ M.Pharmacy
Job Description:
- API Qualification analysis and report preparation
- Analytical Method development and validation for finished products for regulated markets (US and Europe market)
- Handling equipments like HPLC, UPLC, GC dissolution tester, UV/Vis spectrophotometer, IR, KF titrator etc.
- Trouble shoot in existing methods and support regular and stability analysis, Excipient analysis for formulation development
- Preparing reports like method development report, validation protocols and reports, specifications, stability protocols, stability reports etc.
- Preparation of SOP’s & Calibration of analytical instrument
- Support to Formulation & Analytical DoE analysis & Report preparation
- Monitoring of safety in analytical Laboratory
- Maintain GDP and GLP Practices, and Laboratory & Stores in an orderly manner.
Regulatory Affairs (2 – 4yrs)
Position: Jr. Manager
Qualification: – M.Sc/ M.Pharmacy
Job Description:
- Preparation, review, author dossiers/license applications for International markets (USA, EU and Canada).
- Publishing dossier with eCTD software for USA, EU and Canada markets.
- Preparation, review, submission of license documents to State DCA, CDSCO offices and preparation of domestic applications
- Active participation in the regulatory submission strategy designing.
- Coordinating effectively with all cross functional teams (QC, QA, R&D, and Production) to procure the documents and to develop the documents required for compilation of applications.
- Providing Gap analysis, ensuring the accuracy, completeness, quality of documents available, conversion of existing dossiers as per the market specific requirements.
- Evaluation of changes during post submission period, submission of Notification, post approval changes to the approved applications.
- Good knowledge on D&C Act, 21 CFR, ICH and other regulations.
- Provide guidance to manufacturing personnel about latest regulatory requirements and cGMP requirements, fulfilling responsibilities of Regulatory personnel’s during inspections.
- Effectively liaising with State DCA, CDSCO office personnel’s and counter parties.
Note : All vacancies for OSD formulation plants
Location: Hyderabad
Interested and eligible candidate can share their CV to
rnd@defineplacement.com
6752796899
