By admin 
We at Medreich R&D are looking for Quality Assurance professionals for Pilot Plant with 05 to 09 Years of experience.
Location : Hoskote ,Bengaluru
Preferred skill set:
1.Responsible for effective implementation of pharmaceutical quality systems in accordance with the company’s quality policies, national and international regulatory requirements.
2 To ensure the product manufactured in the plant meet the requirements as per the standard operating procedure and cGMP aspects.
3 Review & authorization of written procedures and other documents, including amendments such SMF, SVMP, QMS documents(Change control, deviation, OOS/OOT and CAPA)process validation, Hold time study, Equipment qualifications, Cleaning validation, Facility documents, analytical documents, Stability Study Documents.
4 Monitoring and control of the laboratory environment as per cGMP requirements.
5 To maintain and ensure the data integrity & data governance system in the plant. Monitoring of compliance with GMP requirements.
6 Responsible for review and approval of the standard operating procedure, method of analysis and specification for pilot plant.
7 Provide direct support during internal, customer and regulatory audits and its timely compliance 9.10 Review of quality technical agreements from customers/external agencies.
8 To lead regulatory/customers audits and CAPA complains.
9 Supporting validation / qualification activity and report compilation of different validation / qualification data.
10 Co-ordinate with customer / regulatory in compliance with quality / technical matters.
11 Timely support for the documents transfer to other areas like R&D, Regulatory and other related departments.
12 Compilation of the PV, CV and HTS reports for all the executed batches.
13 Responsible for Raw material packing material and in-process stage release in QLMS and Process order release in SAP.
Please submit your resume: vineeta.k@medreich.com, prashanth.c@medreich.com