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Category

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General Administrative

Description

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The main duties of this role are: 1.   Ensure South African GMP guidelines are adhered to, with specific reference to production and storage of products; the approval and implementation of instructions relating to production operations, validation, production records, and personnel training. 2.   Ensure plant hygiene / cleanliness; the approval and monitoring of suppliers of materials and of contract manufacturers; ensuring records are retained; the monitoring and the control of the manufacturing environment. 3.   Flow of Batch Manufacturing Records: support and coordinate core processes (Production) as well as supportive processes (Supply Chain, Technical Services, Quality Control, etc) on batch manufacturing records. Ensure data integrity through enabling inter-departmental communication, mentoring, coaching and monitoring of the overall process. 4.   Batch Manufacturing Records: drive and make improvements towards a lean batch manufacturing record. Streamline and ensure effectiveness of data collection on a GMP compliant and timely manner and ensure adherence to product registration. 5.   Quality Tools: support and coordinate core processes (Production) as well as supportive processes (Supply Chain, Technical Services, Quality Control, etc) by handling and filing events, change controls and complaints, investigations and impact assessments. 6.   Pharmaceutical Production Structure: ensure 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. 7.   Quality Projects: coordinate and drive effective and timely fulfilment of quality projects 8.   Define corrective and preventive actions to close identified gaps to improve the BMR process. 9.    Contribute to production investigations and gives guidance to production pharmaceutical staff with regards to Root Cause Analysis Level of Education as a minimum requirement:

• B. Pharm / Dip. Pharm.
• Registered Pharmacist with South African Pharmacy Council is a MUST.

Skills and Experiences:

• Minimum 5 years pharmaceutical manufacturing experience with focus on Small Volume Parentals & aseptic manufacturing.
• Excellent pharmaceutical process knowledge essential

• Planning and organizing, Problem solving, Attention to details
• Quality oriented, a team player and possessing the ability to follow work procedures and rules
• Ability to work under pressure

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