Responsibilities:

• Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff
• Create and maintain Site Master Validation Plan
• Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports
• Release of raw materials, components, in-process materials and finished products Review and approve investigation reports as applicable
• Assist in operational investigations to ensure timely completion
• Mentoring, coaching and training of department employees

Requirements:

• Minimum 10 years’ experience in Pharmaceutical Manufacturing QA position
• Experience with MDI/Derma/Transdermal product manufacturing and testing is required.
• Experience with Collection, issuance, destruction, and inventories of all DEA Regulated Controlled Substance /List Chemicals located within WHS Controlled Substance Vault/Cages
• Must be able to review and write SOPs, review test methods, method validation protocols and reports as per FDA and ICH guidelines.
• Have ability to communicate effectively orally and in writing
• Have ability to motivate personnel to work together
• Experience with analytical, stability protocols, reports, batch records, change control, investigations, deviations and other relevant GMP documentation
• Possess organization skills
• Possess analytical mind to deal with issues and offer solutions
• Must be extremely reliable and committed
• Good oral and written communication skill and working in a team environment.