Urgent Vacancy for Jr. Manager- QA/ Regulatory Affairs, Research Scientist- AR&D department at Hyderabad

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:

1. API Qualification analysis and report preparation
2. Analytical Method development and validation for finished products for regulated markets (US and Europe market)
3.  Handling equipments like HPLC, UPLC, GC dissolution tester, UV/Vis spectrophotometer, IR, KF titrator etc.
4. Trouble shoot in existing methods and support regular and stability analysis, Excipient analysis for formulation development
5. Preparing reports like method development report, validation protocols and reports, specifications, stability protocols, stability reports etc. 
6. Preparation of SOP’s & Calibration of analytical instrument
7. Support to Formulation & Analytical DoE analysis & Report preparation
8. Monitoring of safety in analytical Laboratory
9. 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:

1. Preparation, review, author dossiers/license applications for International markets (USA, EU and Canada).
2. Publishing dossier with eCTD software for USA, EU and Canada markets.
3. Preparation, review, submission of license documents to State DCA, CDSCO offices and preparation of domestic applications
4. Active participation in the regulatory submission strategy designing.
5. 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.
6. Providing Gap analysis, ensuring the accuracy, completeness, quality of documents available, conversion of existing dossiers as per the market specific requirements.
7. Evaluation of changes during post submission period, submission of Notification, post approval changes to the approved applications.
8. Good knowledge on D&C Act, 21 CFR, ICH and other regulations.
9. Provide guidance to manufacturing personnel about latest regulatory requirements and cGMP requirements, fulfilling responsibilities of Regulatory personnel’s during inspections.
10. 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