Section Head - Production

Overview Job Title: Mfg. Section Head FLSA Classification: Professional, Exempt Work Location: Fall River, MA Work Hours: General: 8:30 AM – 5:00 PM (may vary based on business needs) Reports To: Mfg. Department Head Salary Range: $83,200 – $104,000 Purpose: Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP and safety to meet the quality and manufacturing targets in time. Key Accountabilities Monitor and control planned production by daily activity review as per production plan to meet production targets and quality standards Review planned production vs. actual production daily and control the production activity of the plant as per the schedule Prepare production schedules for the block and ensure adherence to the schedules Ensure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts Ensure execution of new product & product transfer by performing gap analysis to meet market requirements Review in-process analysis on daily basis to enhance the quality of final product Monitor unit operations and processes to avoid failures Ensure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue Ensure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumables Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering Optimise the utilisation of manufacturing consumables as per the budgets to reduce overhead cost Conduct the daily cross functional AET meeting to continuously improve yield, solvent recovery, reduce OOS, OOT and complaints Evaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown Prepare, review and update GMP documents to meet regulatory compliance and quality of product Prepare the facility and rectify issues related to facility management and documentation for audit readiness Handle investigations, OOS, OOT, change controls, deviation & CAPA in the block Ensure online documentation for any non-conformance to meet GMP by performing surprise checks Prepare and review the qualification, validation and other documents to maintain GMP Participate in the internal and external audits to assure system control Review new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations Ensure adequate and trained manpower availability across shifts to ensure production continuity Ensure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production output Plan and impart training on SOPs, new guidelines and policies to achieve zero non-conformance Monitor employee and workplace safety to maintain safe environment Ensure all operations are performed as per safety norms to avoid accidents in plant Ensure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule Conduct safety training by coordinating with HSE to promote a culture of safe working Implement manufacturing excellence practices for continuous improvement Ensure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue Review the OOE data and monitor the PDCA system to minimize the losses Track monthly change over time of machine to sustain the baseline Prepare plans for utilization of bottleneck machines to reduce time loss Monitor the yield of runner products to ensure yield above baseline Major Challenges: Meeting priority demands during clashing equipment requirements; keeping up with production schedule during facility renovation and equipment upgrade; utilization of capacity as per the production plan due to volatile demand; lead time for regulatory document approvals; availability of machine spares within budget; long cycle times for changes in batch records; quality issues in raw materials; and related mitigation steps Key Interactions Internal and External contacts listed for Quality Assurance/Control, Engineering & Utility, Technical Support, Technology Transfer, Stores and Warehouse, EHS, Capacity planning, R&D, RA, QA/CQA, IT, Central SCADA, OEMs, External Auditors, Equipment tooling suppliers, Maintenance contractors, Civil contractors Key Decisions Scheduling of production batch Utilisation of manufacturing consumables In-process checks Manpower scheduling shift-wise and leave authorization Production Plan forecast to Plant Head OOS, OOT, Complaint Investigation to Plant Head Deviation and CAPA implementation to Plant Head Modification in plant/equipment to Plant Head and Engineering Team Identify products to increase batch size to enhance capacity Development of cost-effective alternate vendors for tools and equipment Modification in qualification documents to Plant Head Education and Experience Bachelor's degree in pharmaceutical manufacturing, industrial management, or related field preferred Minimum of five to nine (5-9) years of experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems documentation in a cGMP pharmaceutical operation environment Technical Knowledge and computer systems skills Understanding of machines used in pharmaceutical manufacturing Ability to influence decision making and facilitate completion of work toward business goals Effective interpersonal skills and ability to work in a team Troubleshooting, investigations and root cause analysis capabilities Capability to handle compliance and regulatory audits at local and federal levels Proficiency in Microsoft Office; SAP experience is a plus; experience in Inhalation products (MDI) is a plus Professional and Behavioral Competencies Proficient in English; self-starter with initiative Willing to work any assigned shift (Day/Evening/Night); schedules may vary Knowledge of GMP and GDP practices preferred Strong written and verbal communication; ability to work in fast-paced environment; strong organizational skills Work Schedule and Other Position Information Must be willing to work in a pharmaceutical manufacturing setting Willing to work any shift (first, second, or third); schedules may be Monday to Friday, or other configurations based on business needs Weekend work may be required Relocation negotiable; No remote work available Working Condition This role works in a cGMP laboratory or manufacturing environment with PPE required (uniforms, lab coats, safety glasses, respiratory protection, hearing protection, etc.). The role may be assigned on a work-shift basis (Day, Evening, Night). Weekend or holiday work may be requested or required based on business needs. #J-18808-Ljbffr