IAssess Consultants LLP
Website:
iassess.in
Job details:
Education
M.Sc. (Chemistry) / B.Sc. (Chemistry) / B.E chemical Engg. / Diploma in chemical Engg.
Relevant Experience
15–16 years in API Production. 5-8 years in a leadership role.
Experience in a bulk drug / pharmaceutical industry in a relevant section i.e. manufacturing.
Computer knowledge for generating, Reports, Plans, training slides, etc, Building of Team
Language Preference
Well conversant in local language (Kannada, Tulu)
Business Understanding
Strong business orientation and skilled in Operations. Financial acumen of the business, operation planning, products, process development, Cost management and Operational Efficiency
Functional Competencies
- Strong knowledge of API production and GMP compliance.
- Deep understanding of unit operations (Distillation, Crystallization, Filtration, Drying) and chemical synthesis.
- Expert knowledge of ICH Q7 guidelines and global regulatory requirements.
- Production planning, batch scheduling and process SOPs
- Strong analytical and risk assessment capability.
- Ability to manage multiple products batch run
- Operational reporting, AOPs, OpEx management
Behavioural Skills
- strong problem-solving skills, Calm under pressure.
- Influencing and stakeholder management skills.
- High emotional intelligence and resilience.
- Strong communication, assertive and relationship-building capability.
Areas Of Responsibility
1 Production Planning & Operations Management
- Plan and execute Quarterly, Monthly and Weekly production plan as per SNOP ensuring optimum utilization of reactors, centrifuges, and dryers.
- Monitor and improve process yields and cycle times through continuous process monitoring and troubleshooting.
- Manage raw material consumption and utilities (steam, power, chilled water) to minimize variances and production costs.
- Ensuring and maintaining housekeeping in and around the production area
- Handling all types of equipment and the modification in the production
2 Quality & Regulatory Compliance
- Oversee the safe handling of hazardous chemicals, solvents, and exothermic reactions.
- Ensure all processes are conducted within the defined "Safe Operating Envelope" to prevent accidents or chemical releases.
- Work closely with the EHS team to maintain an accident-free workplace and ensure 100% usage of PPE by the shop-floor team
- Handling of deviations, change control and near misses.
- Execution of CAPA’s and implement
- Performing investigation in case of failures
- To make sure that all production deviations are reported and evaluated. Critical deviations are investigated and conclusion are reported
- Ensuring clean room procedures are followed as per the requirements
3 People Management and Development
- Oversee a multi-shift workforce, ensuring adequate manning and skill distribution across production blocks.
- Collaborate with HR to identify skill gaps and facilitate developmental workshops (technical/ behavioural training) to team including operators.
- Maintain a disciplined and motivated workforce on the shop floor, addressing grievances in coordination with Site HR/ HR Business Partners.
4 Inventory Planning and Despatch Coordination
- Control inventory in co-ordination with SCM.
- Evaluate inventory level on monthly basis to minimize non-moving / dead inventories.
- Evaluate inventory level on monthly basis to minimise /control over production consumables inventories.
- Coordinate with dispatch team of QC, QA, PPIC, Warehouse and logistics for timely delivery after batch allotments for dispatch.
- Ensure the timely delivery of Products
5 Project Management and Reporting
- Prepare equipment occupancy sheets and explore options to introduce new products.
- Create a detailed work plan which identifies activities needed to successfully complete API project.
- Determine the resources (time, equipment, etc) required to complete the project.
- Review the project schedule with CFT team and monitor.
- Execute the project according to the project plan.
- Co-ordinate with QA, QC and PPIC to give the response to the customer technical queries
- Prepare and share daily, weekly report to Site Ops head and cross functional/ senior leaders.
- Prepare production ORM report of the site. Initiate the scale up meeting in coordination with CFTs.
6 Track wise, SAP and DMS activity
- Review and approval of BMR’s/BPR’s in Track wise.
- Review and approval of department SOP’s in Track wise.
- Perform activities/transaction’s related to SAP and DMS.
7 Stakeholder Management
- Collaborate/ Work with Site Functional Leaders
- Build relationships with local bodies/ government officials.
- Work with Senior leaders and functional Experts
- Timely response to Customers and regulatory representatives
Skills: production head,api production,project management and reporting,track wise, sap and dms activity,people management and development,production planning & operations management,inventory planning and despatch coordination,stakeholder management,quality & regulatory compliance,pharma manufcturing
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