Description: Review executed batch production and packaging records for accuracy, completeness, and cGMP compliance. Verify calculations, yields, and data entries against established specifications ...
Pharma Tech Services
4 jobs near Columbus, OH
Description: Review executed batch production and packaging records for accuracy, completeness, and cGMP compliance. Verify calculations, yields, and data entries against established specifications ...
Effective cross-functional communication (Operations, QC, Regulatory Affairs, Customer Service) * Ability to manage multiple investigations simultaneously while meeting regulatory timelines
Effective cross-functional communication (Operations, QC, Regulatory Affairs, Customer Service) * Ability to manage multiple investigations simultaneously while meeting regulatory timelines
Production Operator I
Royston, GA · On-site
$14.25 - $17.25/hr
Description: * Operate production machinery and equipment according to standard operating procedures (SOPs) and GMP requirements * Follow all GMP guidelines , including proper documentation, material ...
Production Operator I
Royston, GA · On-site
$14.25 - $17.25/hr
Description: * Operate production machinery and equipment according to standard operating procedures (SOPs) and GMP requirements * Follow all GMP guidelines , including proper documentation, material ...
Weekend Production Supervisor
Royston, GA · On-site
Description: The Weekend Production Supervisor is responsible for overseeing daily pharmaceutical manufacturing operations to ensure the safe, efficient, and compliant production of high-quality ...
Weekend Production Supervisor
Royston, GA · On-site
Description: The Weekend Production Supervisor is responsible for overseeing daily pharmaceutical manufacturing operations to ensure the safe, efficient, and compliant production of high-quality ...
Full-time
Posted 8 days ago
Job description
Description:
Review executed batch production and packaging records for accuracy, completeness, and cGMP compliance.
Verify calculations, yields, and data entries against established specifications and SOPs.
Identify and document errors, discrepancies, and deviations in batch records; escalate issues to QA management as appropriate.
Support investigations into documentation errors, OOS results, deviations, and CAPAs as required.
Collaborate with Manufacturing, Quality Control, and Supply Chain to resolve batch record-related issues.
Assist in maintaining audit readiness by ensuring records are compliant, organized, and complete.
Contribute to continuous improvement of documentation practices, workflows, and review processes.
Support preparation for regulatory inspections, client audits, and internal audits.
Participate in drafting, revising, and reviewing SOPs, work instructions, and QA documentation related to batch record review.
Ensure adherence to data integrity and ALCOA+ principles across all documentation practices.
All other activities commensurate with the role, as required
Requirements:Computer savvy
Proficient in Microsoft Excel
Strong communication skill