Duties include:

• Originating, Approving and Issuing Production Documentation
• Originating, Approving and Issuing Standard Operating Procedures (SOP’s)
• Reviewing SOP’s, as per review schedule
• Issuing Stability Documentation, approval of testing protocols, review of stability reports
• Reviewing Validation protocols & validation reports (including process validation, cleaning validation and equipment validation protocols and reports)
• Reviewing Product Development Documents
• cGMP training
• Internal and external auditing
• Investigating and review of deviations and out of specification results
• Review Batch Documentation
• Internal comment investigation
• Change control , vendor certification and approval of suppliers, raw material revie