Block Head – Production, API – Crams, Bidar-Karnataka Full Time

About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels.

Key Responsibilities :

• Responsible for co-ordinating with Process R&D and Technology Transfer teams related to new projects to be initiated in Production.
• Responsible for verification of the new projects initiated in Production Block with respect to desired intend in perspective of Quality, Yield, Batch Cycle Time, Safety, etc.
• Responsible for all the process operations of Production by maintaining the compliance with respect to Safety and Quality.
• Responsible for preparation & review of production schedule in-line with committed targets.
• Responsible to deliver the products in accordance with production plan by considering the specific requirements of the customers.
• Responsible for handling the manpower belongs to Production and deploying the work to them as per their roles and responsibilities.
• Responsible for ensuring the standard operating procedures are being followed on shop floor without any deviations and enforcing the same consistently.
• Responsible to prepare, review and revise the Standard Operating Procedures for all operations & systems from time to time with the support of Quality Team.
• Responsible for ensuring the process operations are carried out as per the batch production records with proper safety measures.
• Responsible for co-ordinating with service departments & ensuring the activities bearing to service departments are completed as per stipulated time.
• Responsible for maintaining & monitoring the Good Housekeeping Practices in process areas and sustaining 5S practices.
• Responsible for all QMS (Quality Management System) documents & its authentication belongs to Production.
• Responsible for initiating, reviewing the documents like BPRs, change controls, deviations, investigations and ensuring the timely closure of it as per the procedure.
• Responsible for carrying out the discussions with cross functional teams in case of any process failures or customer complaints, preparing & reviewing the investigation reports and implementing the suitable CAPA.
• Responsible to prevent failures from re-occurrence by thoroughly investigating the problem to find an exact root cause to achieve quality at Right First Time (RFT).
• Responsible to maintain all previous campaign details to review the quality & quantity trends in reference to the process operations and ensure the consistency for the same.
• Responsible to maintain & manage the inventories & operational expenses of the plant through periodic review.
• Responsible to train & motivate the team on better work methods, safe operating procedures, cGMP, Business Excellence Initiatives.
• Responsible to ensure internal & external audit compliance with respect to safety & quality.
• Responsible to motivate the team for improvements projects like Cost Reduction, Capacity Enhancement and Operation & Quality improvement.
• Responsible for solvent related activities like stock verification, spent disposal, solvent treatment, emission control, etc.
• Responsible to participate Behaviour Based Safety (BBS) programs and enforce & train the team to report all safety related events/ incidents immediately without delay.
• Responsible to prepare & review the qualification and validation documents like VMP, URS, DQ, IQ, OQ and PQ in-line with regulatory guidelines.
• Responsible to prepare a& review HSE documents like process & facility Hazop, Also ensuring the work permit system is strictly followed in the Production Block