- Project Role : Application Lead
- Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact.
- Management Level : 9
- Work Experience : 6-8 years
- Work Location : Pune
- Must Have Skills :CSV (Computer System Validations)
- Good To Have Skills :No Technology Specialization
- Job Requirements :
- Key Responsibilities : 1:Ensure the SDLC deliverables like SSDs, Test Scripts, Promotion Form, Operational Change Form, RTM, DUPRF are as per the SOPs and WIs are reviewed by the team members 2:Ensure the legacy documents are archived according to the record management process 3:Ensure Awareness of existing SOPs Processes and latest templates to team members 4:Consistent alignment with Astellas IS RC stakeholders to ensure expectations are met 5:Review and routing for approve of deviations and CAPA
- Technical Experience : 1:Familiarity with ERP systems 2::Provide validation/compliance guidance to teams 3:Provide support during periodic review, Audits Internal and External 4:Document Management lifecycle,CAPA and Deviation trends 5:Conduct GMP training for new joiners 6:Ensuring Training compliance during SOP revision 7:Managing Escalation and Compliance challenges/issues 8:Support compliance to Client Data Protection 9:Be part of recurring connects with Security and Compliance teams
- Professional Attributes : 1:Presentation Skills 2:Written and verbal communication skills 3:Experience in leading teams 4:Audit experience
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