QA Specialist
at
Medpharma Pharmaceutical and Chem Ind's (L.L.C.)
London, London - England, United Kingdom
-
Full Time
Start Date
Immediate
Expiry Date
09 Feb, 27
Salary
40000.0
Posted On
11 Nov, 26
Experience
2 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
Yes
Skills
Industry
Hospitals & Health Systems
Description
Quality Management System
Raise, review and manage Quality Management System (QMS) records including deviations, change controls, CAPAs, investigations, complaints and quality risk assessments.
Support timely progression and closure of quality records in accordance with internal procedures.
Ensure quality records are complete, scientifically justified and compliant with regulatory expectations.
Support continuous improvement of Quality Management System processes.
Documentation Control
Review and approve controlled documents including SOPs, forms, protocols, reports, specifications and quality records within the electronic Quality Management System (eQMS).
Ensure documentation complies with Good Documentation Practice (GDP) and ALCOA+ data integrity principles.
Maintain document control processes including document issuance, revision, archival and retention.
Support management of controlled templates and quality documentation.
Manufacturing QA Oversight
Perform QA review of Batch Manufacturing Records (BMRs) before manufacture where applicable.
Review completed manufacturing documentation for completeness, accuracy and compliance prior to QP certification.
Provide QA support during manufacturing activities as required.
Support review of manufacturing investigations and manufacturing deviations.
Escalate quality concerns where product quality or patient safety may be impacted.
Laboratory QA Support
Review Quality Control documentation including specifications, analytical methods, sampling instructions and protocols.
Support review of analytical investigations including OOS, OOT and atypical results.
Review laboratory documentation to ensure compliance with GMP, GLP and internal procedures.
Support QA oversight of reference standards, retained samples and stability documentation where applicable.
Materials Management
Perform QA review and disposition of starting materials, packaging materials and finished products in accordance with approved procedures and delegated QA authority.
Support supplier qualification activities including supplier assessments, audits and technical agreements.
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