pharmacy consultant - , FL, United States - Medisca

Description

Medisca is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30+ years and a strong foundation in pharmaceutical compounding, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. From pharmaceutical compounding products and services, to supply chain solutions, mixing technology manufacturing, analytical testing, IP licensing, to education services and more - Medisca delivers extensive solutions that leverages a strong network of partners committed to deeply caring about people. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives, across a multitude of needs and across a multitude of people.

The primary goal of thePharmacy Consultantis to be a subject-matter expert to both Medisca's cross-functional teams, responsible for servicing and educating our clients, as well to Medisca clients for all 503B compounding pharmacy needs. The incumbent will be interacting with internal teams and clients to provide direction on regulatory compliance, cGMP, environmental monitoring, quality assurance, validation and qualification, facility design, aseptic processing, continuing education and our product portfolio (technology, equipment and reusable/disposable supplies), as it pertains to 503B Outsourcing Facilities.

As a Pharmacy Consultant, you will be a Consultant for the US market.

Ideally the Consultant is based in Texas, Florida and New York. Candidates in other US States may also be considered.

Youhave:

• Comprehensive knowledge of DQSA, applicable FDA Guidance, DEA regulations, 21 CFR Part 210 and 211 and USP.
• Comprehensive knowledge of current standards of practice in sterile compounding; USP <797> required.
• Ability to function as a subject-matter expert and consultant in the following areas (non-exhaustive list):
• Product Specialist (technology, equipment, and reusable/disposable supplies).
• Procurement of products, equipment and devices for the 503B Outsourcing Facility.
• Automated technology and robotics.
• Quality systems.
• Quality assurance and quality control.
• Continuous quality improvement.
• Aseptic processing.
• Process validation.
• Analytical and microbiological testing.
• Facility design.
• Environmental management and monitoring.
• Sanitary conditions.
• Operational support and workflow.
• Mock audit.
• Formulation development.
• Batch production and master formulation review.
• FDA Product submissions.
• Standard operating procedure customization and review.
• Pharmaceutical calculations.
• Ability to function as an onsite third-party evaluator.
• Demonstrated ability as a technical expert in aseptic processing, servicing and training.
• Expertise to potentially assist in the development and implementation of Continuing Pharmacy Education activities; live and self-directed learnings.
• Expertise to potentially assist in the facilitation of Continuing Pharmacy Education activities.

Skills, knowledge and abilities:

• 5-10 years' experience as a compounding pharmacist in a 503B Outsourcing Facility.
• 2-5 years' teaching experience (e.g., preceptor, lecturer, facilitator, etc...) an asset.
• Regulatory and Standards of Practice Expert
• Product Specialist
• Active participant in National or State/Territory policy discussions, State Boards of Pharmacy advisory or committee member, etc. an asset.
• Demonstrated leadership abilities (e.g., committee chair, group leader, etc.)
• Demonstrated motivational assets (e.g., captivating, personable, approachable, etc.)
• Proven abilities to apply judgement, ethical practice and decision-making skills.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.

#LI-Remote