Role & responsibilities
- Preparation of project concept note and project definition.
- Preparation of project milestone schedule.
- Layout Review and to follow up with all stake holders for review & approval.
- To Prepare CAPEX based on the realistic approach keeping the focus on overall project timelines, cost & technologies.
- To timely escalate cost over runs or for the additional scope of work to Project Head.
- Prepare and Review Planning / Schedule of overall project.
- Review of Design Data Sheet (Utility, HVAC, Electrical).
- Project monitoring, liaison and co-ordination with consultants, vendors, and cross functional team.
- Utility designing and selection as per process / product requirement.
- Preparation and or Review of URS of utility equipment.
- Designing and selection of clean utilities based on consumption profile.
- Preparation and or Review of technical comparison of all vendors.
- Review of P & ID and documents.
- Responsible for preparation & review of qualification, validation documents, SOPs & QMS documents.
- Responsible for supervise all vendor activity for all streams.
- Responsible for periodic revision of the list of approved layouts.
- SOP and other required documents like Addendum study protocols preparation and review.
- To monitor, review and update progress of execution and qualification activity for facility.
- Ensure Site Readiness and allied activities are done with meeting required timelines.
- Co-ordination with Purchase team for Equipment Ordering and Finalization.
Preferred candidate profile
Candidate should have experience in Biotech / Pharmaceuticals IndustryExperience in greenfield projects is must.Skills Required
Project Management, Agile Methodologies, Risk Assessment, Budgeting, Stakeholder Management