Executive - QC Instrumentation
Sun Pharmaceuticals, Inc, Indiana, PA, United States
Role Purpose
The incumbent will be responsible for
maintenance, calibration, qualification, and troubleshooting of QC laboratory instruments
in a
USFDAregulated environment , ensuring continuous compliance and minimal downtime. Key Responsibilities
Perform
preventive, breakdown, and corrective maintenance
of QC analytical instruments. Handle
installation, qualification (IQ/OQ/PQ) , calibration, and validation support for QC instruments. Troubleshoot hardware/software issues related to analytical instruments. Ensure compliance with
USFDA, cGMP, ALCOA+, and data integrity
requirements. Maintain
instrument lifecycle documentation , logbooks, calibration records, and SOPs. Coordinate with external service engineers and instrument vendors. Support
internal, regulatory, and customer audits
(USFDA, MHRA, WHO, etc.). Ensure proper
change control, deviation handling, and CAPA
related to instruments. Participate in
periodic review, risk assessment, and continuous improvement
activities. QC Instruments Exposure (Desired)
HPLC / UHPLC GC / Headspace GC UVVisible Spectrophotometer IR / FTIR Dissolution Apparatus Karl Fischer Titrator TOC Analyzer pH Meter, Conductivity Meter Stability Chambers and other analytical instruments Qualifications
Diploma / BE / BTech
in any of the following disciplines: Electrical Mechanical Instrumentation Electronics Mechatronics Experience
4 to 9 years
of handson experience in
QC instrument maintenance
within: USFDAapproved pharma manufacturing units OR Regulated QC laboratories Skills & Competencies
Strong understanding of
QC instrumentation and compliance requirements Handson troubleshooting capability Knowledge of
21 CFR Part 11
and data integrity Ability to work in
regulated and auditdriven environments Good documentation and coordination skills We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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The incumbent will be responsible for
maintenance, calibration, qualification, and troubleshooting of QC laboratory instruments
in a
USFDAregulated environment , ensuring continuous compliance and minimal downtime. Key Responsibilities
Perform
preventive, breakdown, and corrective maintenance
of QC analytical instruments. Handle
installation, qualification (IQ/OQ/PQ) , calibration, and validation support for QC instruments. Troubleshoot hardware/software issues related to analytical instruments. Ensure compliance with
USFDA, cGMP, ALCOA+, and data integrity
requirements. Maintain
instrument lifecycle documentation , logbooks, calibration records, and SOPs. Coordinate with external service engineers and instrument vendors. Support
internal, regulatory, and customer audits
(USFDA, MHRA, WHO, etc.). Ensure proper
change control, deviation handling, and CAPA
related to instruments. Participate in
periodic review, risk assessment, and continuous improvement
activities. QC Instruments Exposure (Desired)
HPLC / UHPLC GC / Headspace GC UVVisible Spectrophotometer IR / FTIR Dissolution Apparatus Karl Fischer Titrator TOC Analyzer pH Meter, Conductivity Meter Stability Chambers and other analytical instruments Qualifications
Diploma / BE / BTech
in any of the following disciplines: Electrical Mechanical Instrumentation Electronics Mechatronics Experience
4 to 9 years
of handson experience in
QC instrument maintenance
within: USFDAapproved pharma manufacturing units OR Regulated QC laboratories Skills & Competencies
Strong understanding of
QC instrumentation and compliance requirements Handson troubleshooting capability Knowledge of
21 CFR Part 11
and data integrity Ability to work in
regulated and auditdriven environments Good documentation and coordination skills We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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