Job Description
- Production Planning & Execution for Contract Manufacturing Sites / Loan License Sites.
- Daily Production activity supervision and documentation.
- Production Plan Distribution.
- Identify & Develop New CMOs in accordance with business need.
- Perform Preliminary assessment for the identified CMO in coordination with F&D & CQA Team.
- Ensure Data/Information related to the new products under consideration is arranged from the identified CMO.
- Manage Technology Transfer at New Site.
- Cost Negotiation.
- Material shortages & Indenting.
- Tracking for Daily Production Activity & Dispatches of the FG from different sites.
- Coordination with Purchase Team (RM/PM) for the material requirement & delivery at site.
- PR / PO preparation for Raw Materials / Packing Materials.
- Preparation of Service Purchase Orders for production sites.
- Maintain cGMP at locations.
- Capacity to handle 4 – 5 locations at a time.
- Pack Stock Inspection.
- Procurement of Change Parts for Contract Manufacturing Sites.
- Review of Validation Data.
- Market complaint investigation.
- Site Selection Audits.
- Quality Agreement Preparation.
- Periodic Audits at site with respect to Quality & Inputs.
- Good Hands on Local / Export Market Products.
- Inventory Management at location.
- To achieve the target outputs.
- WIP Statement / Yield Statement Verification.
- Trouble shooting at location.
- Handling of SAP system.
- To maintain record of change part.
- To monitoring the batches at CMU with regular basis.
- To coordinates in audits during qualification of new CMU's and periodical stock audits.
- Familiar with equipments used in Production activity.
- Individually handling lab scale equipment.
- Well trained in Pilot scale up batches.
- Monitor stabilities studies as per ICH guideline.
- Assisting in preparation of technical documents like – Bill of material, Product development protocol, Trial Batch Record, Batch production and control record.
- Evaluate experimental results and plan accordingly.
- Responsible for carrying out scale up activity f newly developed products.
- Troubleshooting of different products and in different areas.
- Good hand on documentation part related with Audits
- Good hand on document review related with production department.
- Reformulation & process development of existing products.
- Cost Cutting / Batch Size Improvement / Yield Improvement.
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Key Skills
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.