201126-Qa Batch Release Specialist

Main Purpose of the Role Perform as a qualified person to review records for batch record release, visual over-inspection of manufactured products, CGMP and GDP record reviews, raw materials and product release, release and verify products for distribution and in-process audits, prepare and review the Annual Product Quality Review as per regulatory guidance.
Responsibilities ? Responsible for review of executed batch records for compliance with current Good Manufacturing Practices, Good Documentation Practices and as per SOPs.
? Perform the raw material and packing material release as per approval from Quality Control Department.
? Perform the Batch record release as per Batch Record review and CoA for batch release.
? Review the Process and cleaning validation protocols and reports for the manufacturing process, facilities and equipment.
? Prepare and review of APQR (Annual Product Quality Review) analyzing trends and notifying any result tending to be out of specification.
? Suppot internal and regulatory inspections related to Batch record review, release and APQR.
¿What are we looking for? ? Professional Graduate.
? Pharmacist/Chemical Pharmacist. ? Knowledge: cGMP, Regulatory Inspection in Manufacturing processes.

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