Executive-Instrumentation
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What you'll do
- Responsible for managing QMS, qualification, and calibration activities to ensure compliance with applicable GMP and quality requirements.
- Hands-on experience in preparation, review, execution, and closure of Change Controls, Deviations, Investigations, and CAPA.
- Experience in timely closure of Change Controls, CAPAs, Deviations, and Investigation reports in compliance with approved procedures and regulatory requirements.
- Knowledge and experience in qualification of instruments and equipment, including preparation and execution of qualification protocols and associated documentation.
- Experience in calibration, verification, and maintenance of instruments, including proper documentation and traceability.
- Experience in updating and maintaining instrumentation and maintenance records in SAP, including calibration activities and timely closure of work orders/maintenance notifications.
- Ability to investigate instrumentation-related failures, perform root cause analysis (RCA), and implement/monitor appropriate corrective and preventive actions.
- Supporting audits and inspections by providing required QMS, qualification, calibration, and instrumentation documentation.
- Strong coordination and communication skills with QA, Production, Engineering, Maintenance, and other cross-functional teams.
What they're looking for
- Diploma/Degree in Instrumentation, Electronics & Instrumentation, Electrical, or a related engineering discipline.
- Relevant experience of 4 to 5 years in Instrumentation maintenance and QMS documentation, preferably in a regulated manufacturing/pharmaceutical/chemical industry.
- Bachelor of Engineering (BE)
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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Division
Piramal Pharma SolutionsPiramal 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
Executive-InstrumentationJob Description
o Diploma/Degree in Instrumentation, Electronics & Instrumentation, Electrical, or a related engineering discipline.o Relevant experience of 4 to 5 years in Instrumentation maintenance and QMS documentation, preferably in a regulated manufacturing/pharmaceutical/chemical industry.
o Responsible for managing QMS, qualification, and calibration activities to ensure compliance with applicable GMP and quality requirements.
- Diploma/Degree in Instrumentation, Electronics & Instrumentation, Electrical, or a related engineering discipline.
- Relevant experience in Instrumentation maintenance and QMS documentation, preferably in a regulated manufacturing/pharmaceutical/chemical industry.
- Hands-on experience in preparation, review, execution, and closure of Change Controls, Deviations, Investigations, and CAPA.
- Experience in timely closure of Change Controls, CAPAs, Deviations, and Investigation reports in compliance with approved procedures and regulatory requirements.
- Knowledge and experience in qualification of instruments and equipment, including preparation and execution of qualification protocols and associated documentation.
- Experience in calibration, verification, and maintenance of instruments, including proper documentation and traceability.
- Experience in updating and maintaining instrumentation and maintenance records in SAP, including calibration activities and timely closure of work orders/maintenance notifications.
- Good understanding of GMP, Good Documentation Practices (GDP), data integrity, and QMS requirements.
- Ability to investigate instrumentation-related failures, perform root cause analysis (RCA), and implement/monitor appropriate corrective and preventive actions.
- Familiarity with controlled documentation, SOPs, logbooks, equipment history records, and audit/inspection requirements.
- Supporting audits and inspections by providing required QMS, qualification, calibration, and instrumentation documentation.
- Strong coordination and communication skills with QA, Production, Engineering, Maintenance, and other cross-functional teams.
Company
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