Section Head - Production

Cipla, Inc•Fall River, MA

3d•Onsite

About The Position

Purpose: Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and manufacturing targets in time.

Requirements

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.
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.
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.
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.

Nice To Haves

Experience using SAP business system and applications is a plus.
Experience in Inhalation products (MDI) is a plus.

Responsibilities

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 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 manufacturing 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