Shilpa Medicare Ltd Walk-in 14th Feb 2025Bsc,Msc,Bpharm,Mpnarm,Any Graduate for Multiple Positions

Shilpa Medicare Ltd Walk-in Interview 2025.Shilpa Medicare Ltd Notification full details below.Interested and eligible candidates can attend Interview on scheduled time and venue.

Vacancy details:

• Post Name:  QC/ Regulatory Affairs- ROW & US/EU/ AQA Formulations
• Qualification: Bsc,Msc,Bpharm,Mpnarm,Any Graduate
• Experienced: 02-10 Years

Important Details :

• Location: Hyderabad/ Secunderabad( Nacharam )
• Selection Process: The selection will be on the basis of Interview.
• Mode of Interview: Face to Face
• Interview Rounds of Interview: HR

Job Description: Greeting from Shilpa Medicare Ltd !!!

Role & responsibilities

• Required for Quality Control(Formualtion)

Quality Control(QC)- Need 2 to 5 years of experience.

*Method validation/Method transfer.

*Analysis of Finshed Product & Stability

*GLP and LIMS, Documentation

Roles and Responsibilities

Should Have Formulation Experience.

• Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions And US/EU Region
• Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions or EU region
• Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format.
• Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities.
• Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration.
• Responding to queries with in the time lines received from client/agency.
• Preparation of check list as per country specific requirements region.
• Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region.
• Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration.
• Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base.
• Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency.
• Filing of variations if any and registration renewals.
• Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments.
• Maintaining the product status (Registered and Under registration) in excel sheet.

Desired Candidate Profile

Should Have Regulatory Affairs Relevant Experience

Role & responsibilities

1. Review and approval of equipment /instruments qualification, calibrations and preventive maintenance documents.

2. Review of analytical method validation/transfer documents of protocols and reports.

3. Responsible for preparation, review and approval of standard operating procedures.

4. Responsible for review and approval of Specification & STPs and analytical work sheets.

5. Responsible for the monitoring of cross functional department activities (like HRD, ENG and ITD log books).

6. Responsible for planning of all analytical Quality Assurance activities like analytical test reports review of Stability samples, finished products, in process, raw materials and packing materials.

7. Review and approval of quality management documents like change controls, and deviations, and also ensuring that these documents properly reported, evaluated, investigated and the conclusion are recorded.

8. Responsible for Review and Closure of Laboratory Incidents, OOS and OOT investigations.

9. Responsible for control of documentation system.

10. To support regulatory department for submission of documents.

11. Responsible for review of OOS trends/summaries.

12. Responsible for on-job training and SOP training.

13. To Co-ordinate with all the departments for smooth working and for better compliance.

14. Responsible for review of relevant documents Le., log books, calibration records, cleaning records and sanitization records etc

Preferred candidate profile

Male Candidates are Preferable.

QC Formulation Experience Candidates are also Eligible.

Walk In Interview 

Date : 14th February , 

Time : 10.00 AM – 2.00 PM

Venue :Shilpa Medicare ltd, Hyderabad Plot No 79, Survey No 125, IDA Mallapur, Uppal Mandal , Kaptra Municipality, Hyderabad, Hyderabad, Telangana, India