Senior Executive-QA

Piramal Pharma Ltd; Kohir mandal; Vor Ort; INR 550.000 - 850.000; Vollzeit

Zusammenfassung

Piramal Pharma Solutions, located in Telangana, is seeking a Senior Executive-QA to review audit trails of chromatography and other instruments, and to release analytical data for intermediates and finished products. The role covers in-process data, stability, IPC data, and system audits to ensure QC compliance.

The candidate will verify logbooks, report incidents, and conduct audits to maintain laboratory system compliance, with MSc as a required qualification and a focus on quality assurance

Qualifikationen

• Must be able to review audit trails from chromatographic and non-chromatographic instruments.
• Must review and release analytical data for intermediates, finished products, stability and IPC data.
• Responsible for in-process data reviews before release.
• Responsible for release of intermediates and finished products.
• Must verify system audit trails of instruments in QC for completeness.

Aufgaben

• Review audit trails of chromatographic and non-chromatographic instruments.
• Review and release analytical data for intermediates, finished products, stability, IPC data.
• Review in-process analytical data before release.
• Review intermediates, stability batches and finished products before release.
• Release intermediates and finished products.
• Review system audit trails of QC instruments.
• Verify logbooks for completeness in QC.
• Invalidate analytical data when required.
• Identify potential contamination or cross-contamination areas.
• Verify SOPs compliance on the shop floor.
• Carry out audits for laboratory system compliance.

Kenntnisse

Audit trail review

Analytical data review

System audit verification

SOP compliance verification

Ausbildung

Master of Science (MSc)

Jobbeschreibung

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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 Executive-QA

Job Description

Review of Audit trails of the Chromatographic instruments and Non chromatographic instruments.
Daily review and release of analytical data of intermediates, finished products, stability data and IPC data

• Responsible for the review of In-process analytical data before release.
• Responsible for the review of Intermediates, stability batches and Finished products before release.
• Responsible for the release of Intermediates and finished products.
• Responsible for the review of System audit trails of the instruments in QC.
• Verification of various logbooks for completeness in QC area.
• Responsible for the invalidation of the analytical data.
• Identify and report the potential areas of contamination/Cross contamination.
• Verifying the SOP's compliance in shop floor.
• Carry out the audits as and when required for laboratory system compliances.
• Report any incident/accident/near miss to the superiors.
• Master of Science (MSc)