Compounding Pharmacist

Hikma Pharmaceuticals • South Brunswick Township, NJ

273d

About The Position

The Compounding Pharmacist will support the Director of Operations / Pharmacist-in-Charge 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.

Requirements

• Bachelor of Pharmacy or PharmD required.
• State of New Jersey license as a Pharmacist is required.
• Multiple state licenses preferred or ability to obtain state license for the following (AL, AR, ID, KS, MI, MS, NV, NY, OH, OK, KY, VA).
• 503B Compounding experience and/or USP 797 knowledge and experience required.
• Knowledge of sterile compounding practices.
• Knowledge of associated standards and operating procedures in relation to cGMP.
• Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.).
• A broad perspective to organize objectives, both long-term and day-to-day activities.

Nice To Haves

• Pharmacist for a 503B outsourcing facility located in New Jersey preferred.
• Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage.

Responsibilities

• Conduct Investigations
• 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.
• Assist the Director of Quality Systems & Compliance in the response to regulatory requests and inspection audits.
• Review, prepare, and/or approve all written responses to audits and inspections.
• Participate in the administration of Site Projects.
• Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
• Provide technical support in the interactions with and applications to state and federal regulatory bodies.
• Provide assistance in collection of documents and records regarding state licensing and renewals for state boards of pharmacy.
• Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
• Maintain current pharmacist licenses in required states, as directed.
• Other duties as assigned.

Benefits

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

What This Job Offers

• Job Type: Full-time
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree