Siemens Pharma MES Quality lead Vacancy 2022 - Apply Online

Siemens Pharma MES Quality lead Vacancy 2022 – Apply Online

Siemens is a market leader in the Process Automation business offering a wide range of products and solutions to our customers in various process Industry verticals.

Pharma vertical is fastest growing vertical within our Process Automation business unit. After a substantial installed base of our Automation and process control systems in last 2 decades, our customers are looking to Siemens for next level of technology solutions like MES, PAT, Simulation, digitalization etc.

Job Title: Pharma MES Quality lead

Location: Thane, India; Bengaluru, India; Pune, India

Job Id: 287461

Profile (Experience, qualification) An ideal candidate should,

  • Have a bachelor’s or master’s degree in Pharmacy or bachelors’ degree in Instrumentation / Chemical Engineering from a reputed institute.
  • Have an overall 10+ years experience in managing quality and validation activities for Automation, SCADA, Historian, MES & related Software projects over complete project delivery lifecycle
  • Have worked for 2+ years in leading and managing quality aspects in core EBR projects execution
  • Have managed end to end complete quality and validation activities including documentation for at least one full medium to large EBR project with own responsibility up to Go live and handover
  • Have deep Knowledge of Pharma Regulatory Guideline such as 21 CFR Part 11, EU Annex 11 & relevant ICH guidelines.
  • Have an overview on ISPE GAMP 5 for CSV.
  • Have exposure of facing regulatory audits such as US FDA, MHRA, TGA etc.
  • Know Pharma Documentation such as drafting of Validation Protocols & Compliance Reports etc.
  • Draft Quality Standard Operating Procedures required for daily usage of EBR in Pharma.
    Manage Audits calendar (internal and customer) and conduct regular internal audits as per Audit calendar.
  • Be a Team player, result-oriented with proven track record of time-bound quality deliverables
  • Have good written and verbal communication skills

Role

  • Own the project delivery from quality and validation perspective
  • Define and manage the overall project validation plan
  • Define the document templates for various validation executables & deliverables (IQ, OQ, PQ, RTM)
  • Manage the execution, review, and approval of various protocols during protocol execution and deployment at site
  • Manage GxP Assessment, prepare Project Validation Plan (PVP), gap Analysis, Risk
  • Assessment (System Level and Functional Level), Impact Assessment etc.
  • Support customers in defining larger MES infrastructure validation from similar experience in other projects

Apply Online

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