Technical Staff

Piramal Pharma Ltd; Barneveld; On-site; EUR 32,000 - 52,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Technical Staff to handle routing process operations with strict cGMP compliance. The role requires completing training before any manufacturing operation, ensuring legible and proper online documentation, and maintaining clean equipment and surroundings.

You will set machine parameters per BMR/SOP, manage changeovers, supervise the line, and address any non-conformities promptly while adhering to safety and quality standards.

Qualifications

Responsibilities

• Handle routing process operation with strict cGMP compliance.
• Complete training before any manufacturing operation and maintain SOP-compliant documentation.
• Set machine parameters according to BMR/SOP and perform changeovers.
• Keep equipment and work area clean; report non-conformities.

Job description

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

Technical Staff

Job Description

She/he is capable for handling routing process operation without error with cGMP compliance

• To take training before execute any manufacturing operation and use Ensur for training (If user Id available).
• To be committed when fill the document contemporaneous (online), Legible, Readable,
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• To be committed for GDP practices to avoid overwriting and errors, etc. in documents.
• Use self-login ID and password & do not share it to anyone.
• Follow instruction for new machine/methodology in accordance with the quality standards.
• Clean the equipment’s and line for Type A, B & D type in case of product / batch change and major mechanical related maintenance job.
• Visually check for the absence of any residue of previous product or any extraneous matter.
• Do status label as per SOP.
• Use appropriate personal protective equipment’s like face shield, Goggle, Hand gloves & nose mask during machine operation, machine cleaning and follow safety regulation.
• Know hazards associated with given product/ machine/equipment/ tools and adopt necessary protection against identified hazards.
• Identified the Hazards & report any near miss, unsafe act, unsafe condition to your supervisor immediately.
• To maintain good hygiene, safety practices and cGMP Practices.
• Takes the changeover on the machine from product to product or batch to batch as per SOP.
• To set the parameter of machine as per defined in the BMR/SOP.
• Check the Raw material / SFG product name, batch number, weight of material, sieves, FBD bag, bellow and punch set as per BMR, if any mismatch inform to supervisor.
• To check the visual defect periodically.
• To run and supervise the machine as instructed by line/ shift superiors.
• Handle the rejection as per defined in the SOP.
• In case of any non-conformity or deviation inform the line supervisor immediately.
• Keep the machine clean throughout the shift along with surrounding area.
• Ensure there is no spillage of material on the floor.
• Delivers the expected output from that machine in the shift.
• Address the minor mechanical issues in terms of machine setting from time to time and inform supervisor during any breakdown where maintenance helps are required.
• Knowledge and involvement in SFTI & 6S Activities.
• Knowledge and involvement in ISO 14000 & 13485.
• Check and review the BMR before start of next operation.

Any other activity from time to time which his supervisor / company feels appropriate.