À propos de ce poste QA Technician chez Piramal Pharma
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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
QA TechnicianJob Description
The Quality Technician will assist the QA officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. Be the QA representative for new campaigns dealing with aspects including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition. The QA Technician is expected to identify and escalate cGMP issues that have the ability to effect batch quality.Key Responsibilities
Provide QA support to GMP manufacturing, testing, and support activities in line with approved procedures.
Review and approve master/executed batch records, validation and other documentation, and associated GMP records to ensure accuracy, completeness, and compliance.
Support deviation management, including initiation, investigation support, assessment/ review and closure.
Review and approve QMS records in accordance with authorised roles, including deviations, change controls, CAPAs, and risk assessments.
Support material status control and batch lifecycle activities, including readiness for batch disposition.
Ensure adherence to data integrity principles and GMP requirements across all assigned activities.
Support regulatory inspections, client audits, and internal audits through preparation and review of QA documentation.
Collaborate with Operations, QC, MSAT, Supply Chain, and Regulatory functions to resolve quality issues efficiently and compliantly.
Promote a strong quality culture and continuous improvement mindset across the site.