Job Description
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 Industry
- Experience in greenfield projects is must.
More Info
About Company
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing organization in the world. It has been growing at 19% CAGR and crossed the $2.5 billion mark in the past financial year. The company has set up a network of subsidiaries, under the name Accord Healthcare in the EU, US, Canada, SA, Australia, APAC as well as CIS & MENA regions. Intas is present in 85+ countries, with more than 70% of its revenue coming from global business.
Currently ranked 6th in the Indian pharmaceutical market, it’s the largest privately owned Indian generic pharma company. Intas has established leadership in key therapeutic segments like CNS, Cardio, Diabeto, Gastro, Urology, Oncology & Animal Health in India. We are among the top 10 generic players in the highly regulated markets of EU, US & UK.
Intas operates 17 advanced formulations, R&D, and distribution facilities, of which 10 are in India and the rest in the UK, Mexico & Greece with the help of our 23,000+ Human Capital. Between them, the facilities are accredited by global regulators such as USFDA, EMA, MHRA, TGA, and others. The company invests 6-7% of its revenues in R&D and has over 10,000 product registrations worldwide with a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars, and NDDS products.
Intas' highly advanced EU-GMP Certified Biopharma division is fueled by a mission to provide affordable “Biosimilars for Billions” across niche segments such as oncology, auto-immune, ophthalmology, nephrology, rheumatology, and hormone-based therapies.
The Plasma Fractionation Unit of Intas Pharmaceuticals is a pioneer in manufacturing plasma-derived therapeutics. It houses a full-fledged R&D lab and a state-of-the-art WHO-GMP-certified manufacturing facility complemented with a GLP-compliant QC lab.
Our values of Innovation, Customer Delight, Ownership & Collaboration, Performance Focus & Care for Society are the driving forces toward excellence.