Job Title: Pkg. Section Head
FLSA Classification: Professional, Exempt
Work Location: Fall River, MA
Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs)
Reports To: Pkg. Department Head
Salary Range:
$83,200 - $104,000Purpose: Control 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 Accountabilities
Accountability ClusterMajor Activities / Tasks - Monitor and control planned production by daily activity review as per ppackaging plan to meet packaging 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 packaging 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 for 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 packaging excellence practises 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 the plans for utilization of bottleneck machines to reduce the time loss
- Monitor the yield of runner products to ensure yield above baseline
- Major Challenges
- Meeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning
- Keeping up with production schedule during facility renovation and equipment upgrade
- Utilisation of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans
- More lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups
- Unavailability 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 stake holder i.e. RA, R&D, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder
- Issues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier
- Key Interactions
Internal External - 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 panning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (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)
- 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 Decisions:
Decisions Recommendations - Scheduling of packaging batch
- Utilisation of packaging consumables
- Manpower scheduling shift wise as per production plan and authorization of the leaves accordingly
- 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 Head
- Development of cost-effective alternate vendors for tools and equipment accessories to Plant Head
- Modification in qualification document to Plant Head
Education and Experience- Bachelor'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 Skills- Understanding 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 Competencies- Proficiently 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 Information:
- Must 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. 
