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Responsible for ensuring that all manufacturing machinery and equipments 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 & Responsibilities:
Responsible for ensuring that all manufacturing machinery and equipments 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).
(Briefly describe the essential activities that are performed by this role including key duties/responsibilities. Each statement should start with a verb. Additionally, indicate how frequently it is performed)
Preparation of Standard Operating Procedures, revision of SOPs
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 equipments 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 validationprotocols
Interacting with cross functional team personnel to attain the flow of activities withcompliance
Involved in preparation, participation of aseptic process simulation (media fill) activitiesand media fill planner according to respective protocol
Involvement in planning of production activity based upon API, packing and raw materialavailability, 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 delegateTypical 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 controlsRequirements
Bachelors Degree in Chemistry or Scientific Discipline preferred
3 years pharma experience
At least 1 year experience technical writing preferred
Proficient with Microsoft Office and advanced computer skills Continuous working knowledge of applicable FDA/ICH/DEA regulations Continuous working knowledge of applicable cGMP guidelinesAbility to obtain gown qualificationWhile 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.Benefits
Company benefits includes health dental 401k and standard company bonus
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