Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
The Pharmacist will act as the key operational quality representative with oversight on each process step to ensure final admixtures meet both professional and corporate quality standards. This position has responsibility for ensuring that CIVA is compliant with cGMP, applicable license and Baxter Quality Management System. A strong focus also will be required on managing the flow and prioritization of daily production. This includes directing and maintaining a high level of interaction with production staff. The role also ensures appropriate risk identification processes are implemented in the compounding unit.
Manage the administration of Quality System activities related to Compliance at the CIVA Centre. This includes implementation and maintenance of company policies, Quality Systems and Standards for CIVA; Assure compliance to all applicable Regulatory, Certified Body and Quality System Requirements prior to product release. Collaborate with operations Management and Quality to assess quality risk and address compliance gaps. Provide appropriate admixed product disposition in a timely manner. Ensure admixed batches with associated NCR’s are provided with disposition prior to completion of batch review.
Perform order entry and review, verification and checks during the admixing process.
Co-ordinate workflow and assist other staff members where needed.
Perform final Quality release of products and calculate PN formulations.
Manage daily production activities (Batch, CIVA, TPN, Narcotics) to ensure compliance with SOP’s, and apply expertise in critical production areas to ensure timely and efficient product release.
Maintain audit readiness state and host/participates in internal and external audits.
Receipt, scheduling and entry of orders into the production database according to the validated batch sizes and compounding processes. Communicate with customers regarding unclear orders or delivery schedules as required.
Calculation of parenteral nutrition formulations with reference to the stability guidelines. Maintenance of Finished Product bill of materials where required.
Calculation of worksheets for batch compounding.
Interact with customers to identify / resolve issues and drive systemic improvements to ensure compliance with Quality Standards by investigating non-conformance events, deriving suitable corrective/preventative actions to ensure robust follow up and closure
Review, summarize and incorporate information from pharmaceutical literature related to compounded products and assist manager in new product development.
Respond to requests from customers and Baxter personnel regarding products and admixing services.
• B.Sc. Pharm
• O.C.P. License
Major Subjects / Specialties
• Aseptic admixing or compounding experience
• Antibiotics, Chemotherapy & TPN knowledge and compounding principles
• Knowledge of Good Manufacturing Practice
• Knowledge of USP 797
Type of Experience
• Pharmacy experience
• Hospital and/or retail pharmacy experience
• Pharmaceutical manufacturing or related industry experience
Years of Experience
• Hospital Pharmacy IV Compounding
• Industrial Pharmacy IV Compounding
Additional Skills / Special Training / Technical Skills Required
• Good computer literacy
• Ability to organize and prioritize in a fast paced environment
• Good communication and interpersonal skills
• Strong attention to detail
• Excellent team work and the ability to coach and motivate others
• Ability to work all shifts including weekends, holidays and evenings
• Advanced computer literacy – the ability to learn and become adept with new computer systems
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Thank you for your interest and application to Baxter. All applications will be reviewed and those candidates selected for consideration will be contacted directly.
Baxter is committed to creating and maintaining a barrier-free environment for all employees and customers. We believe in integration and equal opportunity and we are committed to treating all people with dignity and respect.