|Company||Fresenius Kabi Manufacturing SA (Pty) Ltd|
|Location||Port Elizabeth, Eastern Cape, South Africa|
A Senior Quality Operations Pharmacist is required within the Quality Unit division of an aseptic pharmaceutical manufacturing plant in Port Elizabeth.
The purpose of the position is to support operations on quality related matters and projects ensuring streamline and effective collection of quality related data, effective and timely implementation of quality projects as well as the compliant use of quality tools. To support the pharmaceutical structure in production as functional leader.
|Job Functions||Compliance & Regulatory Affairs,Medical,Quality Control|
|Industries||Manufacturing,Pharmaceutical / Medical / Healthcare / Hygiene|
The key responsibilities and tasks of the position are as follows:
•Batch Records Flow: supports and coordinates core processes (Production) as well as supportive processes (Supply Chain, Technical Services, Quality Control, etc) on filling batch records on a scientifically, compliant and timely manner ensuring also data integrity through enabling inter-department communication, mentoring, coaching and monitoring the overall process.
•Batch Master Records: strives and suggests lean batch master records elaboration in order to streamline and ensure effectiveness of data collection on a GMP compliant and timely manner.
•Quality Tools: supports and coordinates core processes (Production) as well as supportive processes (Supply Chain, Technical Services, Quality Control, etc) on handling and filing of events, change controls, complaints, etc on a compliant, scientifically based and effective manner, through inter-department communication enabling, mentoring, coaching and assisting on investigations and impact assessments.
•Pharmaceutical Production Structure: ensures that the pharmaceutical production structure has the necessary competence and training as well as an understanding of their responsibilities through training, mentoring and coaching. Train the pharmaceutical staff on the principles on “Right First Time” BMR.
•Quality Projects: coordinates and strives for effective and timely fulfilment of the quality projects of his/her responsibility.
•Define corrective and preventive actions to close identified gaps to improve the BMR process.
•Contributes to production investigations and gives guidance to production pharmaceutical staff with regards to Root Cause Analysis.
The key requirements for the position:
•B. Pharm / Dip. Pharm.
•Registered Pharmacist with South African Pharmacy Council
•Minimum 5 years Pharmaceutical production experience essential
•Aseptic Manufacturing experience essential
|Job Closing Date||28/02/2019|