QA - Batch Review Specialist

Job Description

Overall Purpose of the Job

Responsible for reviewing the batch manufacturing records and batch packaging records before releasing to the market, and organizing with the assigned EDA inspector for routine visits and submitting the required documents and records to EDA.

Primary Tasks

Reviewing batch manufacturing records and batch packaging records according to Orchidia’s QMS and relevant SOPs.

Issuing the needed SOPs to illustrate the process in accordance with the cGMP.

Reviewing all the products’ certificates in different stages.

Reviewing the environmental conditions conformance during the production process.

Verifying the products and batches data comparing to the batch record.

Reviewing the raw materials status and their conformance.

Follow up the receiving of APIs consignments to be submitted in the EDA.

Organizing the EDA assigned inspector’s routine visit.

Preparing and reviewing all the documents that need to be submitted in the EDA.

Issuing final batch decisions.

Investigate and review any received OOS report and come up with the needed actions in accordance with his direct manager.

Deviations handling and investigation till the root causes identified and the CAPA is implemented in accordance with his direct manager.

Archiving and retrieving deviation reports.

Participate in internal or external audit whenever requested, and prepare the needed reports for the conducted audits.

Work through, follow and adhere to safety instructions and requirements.

Work according to GLP, GMP and GDP rules.

Shall be consulted and participated in the EHS management system and its improvement elements via reporting actions / incidents those could occur or occurred and attend the relevant trainings.

Skills

Bachelor’s degree in pharmaceutical sciences or science.

From 1 to 3 years of experience in pharmaceutical industry and operations.

Understanding of methodologies and best quality assurance practices.

Knowledge of documentation reviews and requirements analysis.

Ability to troubleshooting and resolving complex issues effectively.

Ability to work well through others.

Ability to meet workloads and project deadlines.

Excellent English, verbal / written communication.

Excellent computer skills.

Education

Pharmaceutical Science or Science

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