Pkg. Section Head

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
 
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 packaging targets in time. 
 

1. Key Accountabilities 

2. 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 

3. Key Interactions 

4. Key Decisions:  

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

• 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.
• Relocation negotiable.
• No remote work available.

•  Working condition
  This 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.
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