Job Description

• Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs.
• Determine product release for use into the marketplace.
• Control of documentation in compliance with regulation and company policies and procedures
• Related administrative tasks

Responsibilities

Planning and Process

• Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorized by superiors.

Product Release

• Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications.
• Review and approve quality of new, in process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines.
• Approve and release production batches.
• Execute batch release priorities in line with OTIF and planning schedule.
• Ensure release requirements are met for finished products.
• Determine disposition of in process and finished products for clinical and commercial use
• Ensure changes/ deviations in production or quality control have been approved according to QMS.
• Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations.
• Ensure production and QC documentation are completed in compliance with SOPs.
• Monitor and audit compliance to regulatory and in house standards with regards to current GMP
• Report observed deficiencies in process and follow up on corrective action.
• Investigate systematic quality problems and develop preventative plans, in conjunction with Production.
• Provide input into GMP related training needs.

Reporting

• Complete and consolidate standard documents.
• File, archive and retrieve documents.
• Maintain and update records and systems as required.

Skills Required

Background/experience

• Bachelorxe2x80x99s degree with 2 4 yearsxe2x80x99 related work experience, or Post
• Graduate Degree/ Diploma with 1 3 yearsxe2x80x99 related work experience
• Pharmaceutical manufacturing experience

Aspen Pharmacare