Section Head - Packaging

Job Title: Pkg. Section HeadFLSA Classification: Professional, ExemptWork Location: Fall River, MAWork Hours: General: 8:30AM - 5:00PM (may vary based on business needs)Reports To: Pkg. Department HeadSalary Range:$83,200 - $104,000PurposeControl manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and packaging targets in time.Key AccountabilitiesMonitor and control planned production by daily activity review as per packaging plan to meet packaging targets and quality standardsReview planned production vs. actual production daily and control the production activity of the plant as per the schedulePrepare production schedules for the block and ensure adherence to the schedulesEnsure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecastsEnsure execution of new product & product transfer by performing gap analysis to meet market requirementsReview in-process analysis on daily basis to enhance the quality of final productMonitor unit operations and processes to avoid failuresEnsure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogueEnsure maintenance is carried out as per standards to realise optimum utilisation of manufacturing consumablesClose maintenance issues by reviewing processes to meet production targets by coordinating with EngineeringOptimise the utilisation of packaging consumables as per the budgets to reduce overhead costConduct 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 breakdownPrepare, review and update GMP documents to meet regulatory compliance and quality of productPrepare the facility and rectify issues related to facility management and documentation for audit readinessHandle investigations, OOS, OOT, change controls, deviation & CAPA in the blockEnsure online documentation for any non-conformance to meet GMP by performing surprise checksPrepare and review the qualification, validation and other documents to maintain GMPParticipate in the internal and external audits to assure system controlReview new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendationsEnsure adequate and trained manpower availability across shifts to ensure production continuityEnsure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production outputPlan and impart training on SOPs, new guidelines and policies to achieve zero non-conformanceMonitor employee and workplace safety to maintain safe environmentEnsure all operations are performed as per safety norms to avoid accidents in plantEnsure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift scheduleConduct safety training by coordinating with HSE to promote a culture of safe workingImplement packaging excellence practices for continuous improvementEnsure maximum utilisation of the machine in a shift by reviewing reports during shift performance dialogueReview the OOE data and monitor the PDCA system to minimize the lossesTrack monthly change over time of machine to sustain the baselinePrepare the plans for utilisation of bottleneck machines to reduce the time lossMonitor the yield of runner products to ensure yield above baselineMajor ChallengesMeeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planningKeeping up with production schedule during facility renovation and equipment upgradeUtilisation of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plansMore lead time for approval of regulatory documents by internal and external stakeholders. Overcome by regular follow upsUnavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machines.Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stakeholders (RA, R&D, LCM team and CQA). Overcome by defining the timelines for each stakeholderIssues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplierKey InteractionsInternal:Quality Assurance/Control for scheduling of batches, issues in product (Daily)Engineering & Utility for system related queries (Daily)Technical Support for troubleshooting in products (Case Basis)Technology Transfer for support in new products (Project Basis)Stores and Warehouse for RM/PM related activities (Daily)EHS for safety rounds and PPEs (Daily)Capacity planning, R&D, RA other manufacturing units for multiple formula harmonisation and batch size optimisation (Case basis)QA and CQA for preparation and implementation of SOP's (Case Basis)IT for computerised system validation (Case Basis)Central SCADA Team for Real time process data-Acquisition and control (RTPD-AC) project way forward (Fortnightly)External:Original equipment manufacturers for any operation related queries and for machine spare related queries (Monthly)External Auditors during facility audits (as per schedule)Equipment tooling suppliers for any tool related queries and updating the performance of the tools (Case Basis)Maintenance contractor for Instrument calibration scheduling and its execution (Monthly)Civil contractor for civil work (Case Basis)Key DecisionsDecisions:Scheduling of packaging batchUtilisation of packaging consumablesIn-process checksManpower scheduling shift wise as per production plan and authorization of the leaves accordinglyRecommendations:Packaging Plan forecast (To Plant Head)OOS, OOT, Complaint Investigation (To Plant Head)Deviation and implementation of CAPAs (To Plant Head)Modification in plant and equipment (To Plant Head and Engineering Team)Identify the products where we can increase the batch size in existing resources to enhance the plant capacity to Plant HeadDevelopment of cost-effective alternate vendors for tools and equipment accessories to Plant HeadModification in qualification document to Plant HeadEducation and ExperienceBachelor's degree, or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.Minimum of five to nine (5-9) years' experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems related documentation in a cGMP pharmaceutical operation environment.Technical Knowledge and Computer Systems SkillsUnderstanding of machines used in pharmaceutical manufacturing.Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.Effective interpersonal relationship skills and the ability to work in a team environment.Capable of conducting troubleshooting, investigations and root cause identification and analysis.Capable of handling and participating in compliance and regulatory audits at the local and federal levels.Must be proficient in computer skills and software applications such as Microsoft Office tools.Experience using SAP business system and applications is a plus.Experience in Inhalation products (MDI) is a plus.Professional and Behavioral CompetenciesProficiently speak English as a first or second language.Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.Knowledge of good manufacturing practices and good documentation practices preferred.Ability to read, write and communicate effectively.Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.Excellent organizational skills with the ability to focus on details.Work Schedule and Other Position InformationMust be willing to work in a pharmaceutical manufacturing setting.Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.Must be willing to work some weekends based on business needs as required by management.Relocation negotiable.No remote work available.Working ConditionThis role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.GLOBAL COMPANYCipla is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.Cipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.J-18808-Ljbffr