Manufacturing Supervisor – Langhorne, PA
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).
Key Duties and 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
Supervisory Responsibilities:
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
Education and Experience:
Bachelor’s degree in chemistry or scientific discipline preferred
Previous sterile aseptic experience is required
3 years of previous pharmaceutical experience and at least 1 year of technical writing experience
Continuous working knowledge of applicable FDA/ICH/DEA regulations, and cGMP guidelines
