Be the First to Apply
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
Quality products are being manufactured in conformance with cGMP/safety and hygiene requirements on shift-to-shift basis. Maintains overall disciplines and productivity.
· To take training before executing any operation.
· Fills in process parameters in Batch manufacturing record (BMR) and GMP documents.
/ Record where required by following ALCOA + principles.
· 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 and check the equipment like tablet inspection machine (Belt type) /Automatic tablet and capsule inspection machine 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 after machine cleaning.
· Do status labelling as per SOP and proper arrangement of Inspection area.
· Calibrate the balances as per SOP whenever required.
· Clean and dry the uncleaned IPCs and drums whenever required.
· Prepare the Disinfectant solution under supervision as per SOP.
· Operate the inspection machines like Inspection belt and Automatis inspection machine as per SOP.
· Active participation in line operations like Inspection of tablets and capsules, weighing of inspected tablets/capsules and issuance of change parts for automatic inspection machine and it’s documentation as per SOP.
· Use appropriate personal protective equipment’s like face shield, safety goggle, Hand gloves & nose mask during inspection, machine operation, machine cleaning and follow safety regulation.
· Know hazards associated with given product/ machine/equipments and adopt necessary protection as per hazard identification and risk assessment (HIRA) as per site EHS procedure.
· Identify the Hazards & report any near miss, unsafe act, unsafe condition to your supervisor immediately.
· Transfer the semi-finished goods from one area to other area as per the requirements.
· Always maintain good hygienic at workplace/during working in manufacturing/inspection area.
· Set the parameter of machine as defined in the Batch manufacturing record (BMR) and SOP.
· Check and ensure that temperature, RH and differential pressure of inspection area shall be within limit .
· To operate the inspection machine as instructed by shift supervisors.
· In case of any non-conformity or deviation inform the line supervisor immediately.
· Delivers the expected output as per run time of the machine.
· Knowledge and involvement in EHS, SFTI,6S,ISO 14001 and ISO 13485 activities.
· 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.
Any other activity from time to time which his supervisor/company feels appropriate.