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Division
Piramal Pharma Solutions
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.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Senior Manufacturing Technician
Job Description
Supervise the manufacture of high potency ADC/APIs in support of launched products and clinical trial programmes to ensure that they are manufactured in accordance with approved procedures. Proactive approach to suite readiness, structured monitoring, line clearance, BOM/stock levels, sample control and SAP inventory.
Provide training and guidance to less experienced team members. Effectively utilise manufacturing team to deliver the required schedule adherence. Ensure that all GMP documentation is completed “real time” and accurately right first time.
Maintain high ESH standard, carrying out all work in accordance with appropriate ESH policies & procedures. Ensure that 5S and housekeeping standards are adhered to and suites are audit ready at all times.
Key Roles/Responsibilities:
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Supervise the manufacture defined cGMP procedures to deliver high potency ADC/API’s in support of launched products and clinical trial programme.
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Proactive approach to suite readiness, structured monitoring, line clearance, BOM /Stock levels, sample control and SAP inventory.
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Takes on a key role with the introduction of new products , liaising and communicating with relevant departments on highlighted issues
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Ensuring all team members are adequately trained and deliver training as and when required
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Effectively utilise and motivate manufacturing team to obtained the required schedule adherence
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Possess good verbal and written communication skills.
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Ensure that all GMP documentation is completed “real time “and accurately in the aim of right first time.
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Maintain high SHE Standards, carrying out all work in accordance with appropriate SHE systems.
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Ensure that 5S and housekeeping standards are adhered too, and suites are “audit” ready at all times.
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Raise any deviations and REW’s as required. Progress any investigations, CAPA’s to completion through “Trackwise” Quality Management System within the stated timeframe
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Leads continuous progress within the suites.
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Deputies for Shift Team in their absence.
Essential Qualifications
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Degree in a scientific subject or the equivalent GMP experience.
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Possess good verbal and written communication skills
Essential Experience
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Good chemical/bio-processing industry knowledge
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Good working knowledge of GMP
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Understand chemical unit operations and process chemical reaction hazards.
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Possess good verbal and written communication skills
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Experience of working in clean rooms (desirable)
