Manufacturing Supervisor

Department: Manufacturing

Job Title: Manufacturing Supervisor

FLSA Status: Exempt

Reports To: Manufacturing Manager

1. Role Purpose:

Responsible for ensuring that all manufacturing machinery and equipment’s is manned with properly trained personnel to ensure that the production schedule is executed. Ensure that the manufacturing batch records are filled out as per the appropriate Standard Operating Procedures (SOPs).

2. Key Duties & Responsibilities:

• Preparation of Standard Operating Procedures, revision of SOP’s
• Ensuring the Batch records, Standard operating procedures and validation protocols
• Initiation and Implementation of Change controls
• Comply with cleaning and sanitization of manufacturing area including equipment, walls, floors and ceilings per procedure
• Ensure the assembling or set-up of process equipment’s or machines
• Preparation of User Requirement Specifications for equipment
• Actively involved in Batch manufacturing and process validations
• Preparation of Validation protocols for equipment and executing the protocols
• Review of Executed documents, log books, Protocols and batch records
• Conducting the training for batch records, standard operating procedures and validation protocols
• Interacting with cross functional team personnel to attain the flow of activities with compliance
• Involved in preparation, participation of aseptic process simulation (media fill) activities and media fill planner according to respective protocol
• Involvement in planning of production activity based upon API, packing and raw material availability, personnel availability and customer requirements
• Involvement in performance verification of major processing equipment
• Report accidents, unsafe conditions or unusual circumstances to supervisor
  • Comply with FDA guidelines/Company Policies of Data Integrity
  • Understand and adhere to all cGMP and FDA regulations
  • Execution/ coordination of validation protocol testing
  • Other duties as required or delegated

3. Typical Supervisory Responsibility:

• Supervise the daily actives and tasks to be performed to support the batch production
• Become the SME for the manufacturing process and equipment
• Write and modify SOPs for the manufacturing process
• Train operators
• Work with scheduling and warehouse to assure we setup for production schedule
• Assist with the writing of deviations/investigations and change controls

4. Education & Experience:

Bachelor’s Degree in Chemistry or Scientific Discipline preferred

Experience Requirement

3 years pharma experience

At least 1 year experience technical writing preferred

5. Technical competencies/ Certifications/ Licenses:

• Proficient with Microsoft Office and advanced computer skills
• Continuous working knowledge of applicable FDA/ICH/DEA regulations
• Continuous working knowledge of applicable cGMP guidelines

Certifications

N/A

Licenses

N/A

Other

Ability to obtain own qualification

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A