Unit Head (API)

Job Description

Recruiter Mohaneswara Reddy https://www.linkedin.com/in/mohaneswarareddy Role & responsibilities I. Unit Strategy - Strategic Capability Plan Develop and secure approval of the Unit Annual Strategic Capability Plan for the Unit and drive its implementation within allocated budget and resources. Contribute to Site Strategic Capability Plan development & implementation. II. Integrated Quality & Product Safety - QMS, cGMP & Product Regulatory Compliance: Ensure cGMP compliance of the unit by building, assessing and tracking the systems and controls at unit to meet regulatory and customer requirements Establish, implement, monitor & review a system of proper verification and exercise of due diligence through periodic institutionalized reviews / audits and Gemba walks with the Unit Teams to ensure that: all cGMP, Product Regulatory & Customer requirements are met for the Unit; batches are produced in controlled manner in accordance with approved dossiers and requirements of Marketing Authorization ensuring that the product is safe, efficacious and meets the quality standards; QMS is implemented & continually improved for the Unit in collaboration with the Site/Unit QA&QC Teams, with a focus on: TRUST - a Strategic Quality Culture Initiative; Ontime closure of investigations (Complaints, Deviation and valid OOS); RFT: Improve RFT % (# of batches RFT without non-conformances - Valid OOS); Trend of repetitive Deviations and CAPA effectiveness [% No Repeat Deviations]; Escalate any gaps to the Senior Management and drive identification, development, implementation and closure of CAPAs. Ensure ALL TIME READINESS for audits. Ensure integrity of documentation & compliance to cGMP for continuous improvements in quality and systems Monitor the quality score of unit and all related dimensions to meet the set standards Ensure the implementation of quality systems policies and generate action plans during Quality Management Review. Monitor the quality risk management process to ensure that it is defined, deployed and reviewed as per laid down procedures Ensure that the appropriate validation, qualification and calibration of equipment and apparatus are performed and recorded by conducting review meetings Prepare facility for audits by random facility checks, closing internal and corporate audits recommendations Prepare action plan in-coordination with QA for any findings in regulatory and customer audits and ensure compliance Ensure facility readiness in collaboration with individual departments and engineering team Handle the regulatory audits by coordinating with CFTs for smooth execution III. Occupational Health & Safety and Environment Sustainability for Unit Operations- Monitor and ensure adherence to EHS standards and statutory compliance through periodic reviews. Implement, monitor & review adherence to EHS Policy, standards, relevant elements of statutory compliance and EHS strategic initiatives for the Unit through a periodic institutionalized reviews / audits and Gemba walks with the Unit Teams and Site EHS Lead. Escalate any gaps to the Senior Management and drive identification, development, implementation and closure of CAPAs with support from Unit EHS Lead. Review the assessment of the risks involved in critical processes, operations and equipment [Process Safety | CHAMP] by EHS Teams & SMEs; Ensure that these are mitigated to acceptable levels. Review the safety trainings and mock drill completion for entire Unit Team with support from Unit EHS Head. Ensure that the Unit Teams has adequate pre- employment, pre-placement and on the job EHS training to meet the Unit Operations EHS Requirements. Review the Fitness Certificate and trending of Key Health & Hygiene Data Points of impact unit team to ensure that any adverse heath impact is prevented. Review the Environment Performance KPMs of the Unit to ensure compliance with company & statutory requirements. Provide visible felt leadership to the Unit Team on EHS agenda and drive implementation of the BOS program with an intent to move towards INTERDEPENDENT EHS CULTURE. Monitor & Review the reporting of all EHS near misses and incidents for comprehensiveness; investigations of all incidents and accidents for adequacy & quality of RCA and CAPA identification. Monitor & ensure implementation of CAPAs by regular review Ensure Safety Committee meeting is conducted at unit and participate in the same as a Chairman Participate in the safety audits and ensure CAPA implementation and face the safety auditors for clearance of same where required Review & assure oneself on the emergency response & preparedness and evacuation plan of the unit IV. Operations Excellence for Unit Operations- Establish new systems and drive continuous improvements through Jagruti and Operations Excellence initiatives to reduce production cost, better quality and facilitate smooth & safe operations Drive continuous improvements through Jaagruti and other Operations excellence initiatives in collaboration with MSTG & Site OE Lead to drive efficiencies in Unit Operations and improvements to best in class benchmarks on specified measures with a specific focus on following areas: Process Simplification & Optimization Review & Optimize Unit Operations Achieve cost reduction through yield improvements time cycle reductions scale-ups formula harmonization chemistry optimization New technology Automation Drive continuous improvement in Product & Process Robustness through Jupiter review for Unit Products in collaboration with the MSTG Team bodies Monitor and control the budget for the manufacturing unit and Reduce operational costs by planning and executing interventions leveraging LSS and DAA V. Product Availability for Unit Operations [Business Plan Execution]- Agree and approve production commits (including New Product Launches & Product Registration) from the Unit in the framework of annual budget and the S&OP Requirement from the Unit. Reasons for Requirements vs Commit gaps should be documented and approved. In case the Requirement is below the Approved Budgetary volumes escalate to Site / Cluster Head and work towards additional volumes to fill capacity to operate at optimal levels. Drive adherence to the production commits by coordinating requirements for resources and materials for all departments at the Site to meet production targets. Approve and monitor the production schedules and requirements for resources and materials for all departments in a unit to meet production targets Review & monitor implementation of production schedules for all the departments in the unit and take backup / contingency actions as required to ensure that commits are delivered. Review and approve the forecasts, production planning, resource planning Provide guidance to warehouse for scheduling the RM, PPM, and PM as per production plan. Ensure cross-functional coordination by tracking plan for timely delivery and sustainability Review delivery vs requirements of all the department as per production schedule Maintain operational efficiency by guiding department heads to resolve issues and drive improvements. Identify the bottlenecks in the course of planning and mitigate the same Review production mechanisms, resource utilization and delivery progress for efficient production VI. New Products & Filing for Unit Operations [Business Plan Execution] -. Ensure smooth supply for new product launches and filing Ensure early engagement into the Tech Transfer process as the Receiving Unit, starting with QbD3 & FRM and be the Owner of the ESM Step of the TT Process engaging with the cross functional teams to enhance quality of Gap Assessment, Tech Discussions, Risk Recognition & Mitigation. Support timely Tech Transfer by optimizing the utilization of resources to avoid delays and meet the timelines Plan & support department heads for new product technology transfer and execution of validation batches. Review documents like risk assessment, gap analysis, product transfer reports, guidelines, FMECA etc. in coordination with Tech Transfer team for the implementation of new product. Monitor timely delivery of new products by conducting review meetings with the cross-functional departments Monitor resource planning for the hassle-free execution of new products Provide technical support to RA for the deficiency responses of regulatory bodies VII. Cost Management [Business Plan Execution] Ensure Budget Adherence for Unit Operations Monitor and control the expenses of unit OPEX Manpower Cost CAPEX Implement frugality by implementation of new ideas and alternatives prevent and reject unjustified OPEX and CAPEX requisitions and provide the way forward VIII. Asset Care [Engineering & Projects] Ensure Operating Capability for Unit Operations through maintenance of facility and equipment by collaborating with engineering to meet production schedule, regulatory expectations and facilitate smooth and safe operations Ensure maintenance of the Unit facility and equipment by collaborating with Unit Engineering Lead to meet production schedule, statutory & product regulatory expectations and to facilitate smooth, safe and compliant operations through institutionalized reviews covering but not limited to Annual turnaround maintenance Preventive maintenance schedules; Calibration schedules Equipment health and validation status; Maintenance documentation required per cGMP & product regulatory requirements; Deviations / Change Control & CAPA in the Engineering domain. Review the capability of Unit Engineering Team in consultation with Unit Engineering Head to assure adequate capability depth in Unit Engineering. Review Breakdowns to assess adequate RCA and CAPA to minimize breakdown. Conduct random audits through Gemba Walks with the Unit Engineering Team and review of facility for adherence to cGMP and safety guidelines and monitor the consequent CAPA for timely implementation. Ensure installation and qualification of new systems required for new products and technology upgrade in the equipment and software by conducting regular project meetings IX. People Capability for Unit Operations - Drive people development by spearheading tactical and strategic initiatives within the unit at a site to maximize performance and achieve better control of operations Ensure for the Manufacturing Unit Adequate Manning to meet the Budget Volumes in compliance with cGMP and EHS Norms and standards and statutory compliance Develop & secure the approval for Manning budget Ensure that the Unit has 95%+ manning always Ensure that personnel engaged in manufacturing of Pharmaceutical products are duly competent education, training and experience carry requisite certification and refresher training and certified as medically fit for the duty. Drive people development by spearheading tactical and strategic initiatives within the unit in alignment with the global operations & corporate guidance. Provide coaching and leadership to Direct Reports and conduct structured communication with larger Unit Team to create an environment conducive to high performance. Monitor and review the training imparted to the larger Unit Teams including production techniques, procedures and principles of cGMP, EHS, Engineering, Soft Trainings by Corporate HR including audit skills, mandatory corporate trainings X. Performance Management for Unit Operations Build high performance teams - leveraging the HPT Model driving Ownership, Relationship, Knowledge & Discipline Increase team accountability by clearly outlining expectations and ways of working through an quarterly & annual performance dialogue Drive, monitor, review and ensure adherence to Unit Goals & Performance Objectives by appropriately leveraging the Cipla Rewards & Recognition Program Recognise disciplined execution & excellence, innovation and going beyond the call of duty. Liaise with HR for grievance redressal of the team. Major Challenges Optimisation of capacity utilisation in multi-product facility due to product mix and volatile demand. Overcome by periodically reviewing the production schedules and prioritizing the demands Availability of facility for new products and legacy products together if demand clashes. Overcome by efficient planning of resources Managing the production in high attrition rate. Overcome by mentoring, guiding and replacements Realization of the Strat plan v/s resource planning. Overcome by periodically reviewing and escalating Underutilized lines keeping fixed costs high. Overcoming by co-ordinating with capacity panning team Disposal of IPD non-moving inventory from the stores causing space constraints. Overcoming by regular monitoring and highlighting to IPD and purchase Regulations monitoring the operation of manufacturing units are dynamic and continuously evolving. Overcoming any possible shortcomings by being aware of the changing policies and ensuring their continuous implementation and monitoring Managing the criticalities of a highly volatile socio-political environment. Overcoming by being able to forecast upcoming changes and maintaining an adaptive workforce and latest manufacturing technology Intense competition in market exists in terms of new product launches in a rapidly changing environment. Overcome by ensuring smooth and seamless facility for new batches to be realized at the earliest, for registration and trial Regulatory reforms require intervention of Corporate Internal Audit teams. Ensuring a smooth coordination between teams at the Unit and at the Corporate for seamless execution of their recommendations. Ensure Risk assessment and mitigation for all Unit operations by doing a detailed study to find out the critical and vulnerable areas and ensuring that they are de-risked adequately. Number of Dosage/ Platform Digital Journey Preferred candidate profile Educational qualifications: B.E / B.Tech Chemical Relevant experience: 15+ Years of experience in pharmaceuticals manufacturing with 8+ Years of experience at Senior Management Level. Understanding of pharmaceuticals manufacturing operations, Quality, Regulatory, Safety, legal & cGMP systems Skillset includes : leadership skills, strategic thinking, decision making, problem solving, business acumen Recruiter Details Mohaneswara Reddy https://www.linkedin.com/in/mohaneswarareddy