Manufacturing Operator

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Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions Process & Pharmaceutical Development services Clinical Trial Supplies Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

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Job Title

Job Description

Job Overview

Reporting to the Production Supervisor the Manufacturing Operator performs production related activities including component preparation filling capping autoclaving terminal sterilization compounding and lyophilization production.

Shift:

Nights

Reporting Structure

This position reports to the Production Supervisor.

Key Responsibilities:

Consistently comply with all applicable policies and procedures including those regulated by PPS and various regulatory agencies
Performs line clearances cleaning/sanitization cleaning preparing and sterilization of fill equipment sterilization of components operation of aseptic filling equipment filter testing operation vial washing equipment
Operate and maintain production related equipment
Weigh measure and check raw materials to assure batches manufactured contain proper ingredients and quantities
Execute validation protocols for processes and equipment
Maintain records and a clean environment to comply with regulatory requirements
Read understand and comply with Good Manufacturing Practices and Standard Operating Procedures.
Review current SOPs and provide feedback on potential process improvements
Participate in troubleshooting and process improvement activities including corresponding documentation activities
Review completed production documentation (batch records log books etc.) for quality and cGMP compliance
Initiate appropriate action when process deviations occur
Perform on-the-job training for new and developing operators
Routinely perform housekeeping assignments maintain cleanliness and routine maintenance of the work area and equipment
Collaborate effectively and communicate with other functional groups including: quality validation supply chain to ensure production goals are achieved

Qualifications:

High School education or equivalent

2 years working within an industrial or manufacturing environment
Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred

Mechanical aptitude ability to operate processing equipment
Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP OSHA FDA)
Ability to read interpret and follow written instructions
Team player committed to quality and working effectively with others
Track record of consistent attendance and overall reliability