Responsible for the continuous development and maintenance of Quality Systems at the B& L Tampa Pharmaceuticals Organization. Will also be responsible for various Quality System process improvements and Quality Assurance/System projects and Identifying and addressing Compliance Gaps. Work with cross-functional teams to develop/improve Quality Systems
Mentor, coordinate and manage the Aseptic Training team to ensure that Training requirements are met. Ensure timely completion of garment excursions.
1. Performs a wide variety of activities to ensure Quality System compliance with applicable quality objectives and regulatory requirements.
2. Partners with other organizations to develop, design and deliver robust GMP records and training methods. Develops and delivers high quality and high impact learning products, programs and services that provide functional GXP processes and product knowledge for staff.
3. Supervise staff in connection with developing and delivering aseptic training materials and conducting Environmental Excursions.
4. Evaluates the effectiveness of site Quality Systems including but not limited to GMP Compliance, Data Integrity, Training, Change Control and Management Review
5. Collaborate with cross functional teams to develop and track Quality System objectives and deliverables.
6. Responsibilities also include interviewing, hiring, terminating and employees; planning, assigning, and directing work; appraising performance; counseling employees; and conflict resolution.
7. Keeps abreast of the requirements for compliance in area of responsibility. Participates as required on regulatory issues affecting own area of work. Elevates compliance questions and issues.
– Minimum of BA/BS
– Supervisory leadership and training/training material development experience in the pharmaceutical industry.
– Experience with a broad array of Pharmaceutical Manufacturing Quality Systems and processes. Experience in executing process improvements as well as identifying and closing Compliance gaps in these areas.
– High level of competency of MS office applications such as
MS Word, Excel and Access
– 5+ years of experience in Training Compliance in a
Pharmaceutical Manufacturing GMP Environment or equivalent.
– Adept with presentation skills to deliver broad material to an audience.
– Experience in the administration of ComplianceWire is strongly preferred
– Experience with other Pharmaceutical Manufacturing Quality Systems.
-Aseptic processing knowledge a plus
Refer this job to a friend
Bausch Health Companies Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
**Job ID** _12290_
**Pos. Type** _Full Time_