Compounding Pharmacist

Purpose

The Compounding Pharmacist will support the Associate Director of Operations and is responsible for supervising production operations of Compounded Sterile Preparations by implementing and maintaining Sterile Compounding policies / strategies in alignment with all regulatory authorities / guidance's and Hikma Corporate plans and policies. The Compounding Pharmacist will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements.

Key Accountabilities :

• Ensure adherence to batch records and aseptic techniques.
• Monitor Compounding personnel for compliance with gowning, behavior and aseptic technique.
• Conduct Investigations for manufacturing deviations.
• Execute CAPAs & Change Controls.
• Provide Aseptic Training
• Provide oversight of compounding and production activities, ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
• Keep abreast of relevant guidance documents pertaining to 503B production.
• Monitor and communicate changes in regulations of all state and federal regulatory agencies.
• Assist in new 503B product development, including collaborating on labeling, stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.
• Attain all non-resident Pharmacist licenses within 1 year.

Primary Accountabilities :

Qualifications : Minimum :

Experience : Minimum :

Skills :

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