Pharmacist Intern wanted Immediately: APPLY HERE
Quality Compliance Manager / Deputy Responsible Pharmacist
MAIN PURPOSE OF JOB
Purpose is to fulfill the internship training requirements whilst adding value to Fresenius Kabi processes.
Education: Formal Qualifications
Level of Education:
University degree (Pharmacy) BPharm
Skills & Experience:
Interest in manufacturing Pharmaceutical industry
Attention to Detail
Key responsibilities and tasks:
· Design, control and maintenance of SOP’s
· Ensure that SOP’s relating to the relevant department are maintained, new SOP’s developed where necessary
· The quality system documentation is kept current and relevant.
· Ensure all copies of documentation are controlled as per SOP and that no unauthorized and
out dated versions are in use.
· Global SOP integration into local business
Implementation of QA and QC Systems
· Carry out regular audits / walk about checks of the areas.
· Ensure compliance with SOP’s
· Ensure training in all content of SOP’s, including GMP, GPP, GWP, GLP.
· Ensure full knowledge of all Quality Management systems, including Deviation
· Process, Change Control Process, CAPA and release process
Customer complaints handling:
· Compliant Receipt and Triage
· Closure and communication with customers
· Review of Product Manufacturing and Packing Documentation.
· Syspro transactions
· Approval as per release specifications
· Post Importation Testing
· In-Process Control during compounding
· Environmental Monitoring
· Product Microbiological monitoring
· Planning of Production Batches
· Monitoring and Knowledge of various production processes, including sterilisation of equipment, compounding, etc
· Ensure that all weight verification checks for filled TPN bags are performed and recorded during the packaging process.
· Ensure that all QA label verification checks are performed during TPN packaging processes.
· Ensure that BRLs are printed, batch numbers are populated and that the information written on the BRLs is correct before daily production commences.
· Double check all printed labels for the TPN bags and pouches before production commences.
· Timeous preparation of consumables (i.e. gloves, cleaning clothes, scissors, pens, detergents, etc.) for gamma irradiation and notify the store man when stock levels are low.
· Ensure that all batch reconciliations are verified after packaging processes and all
batches are sent for irradiation and recorded accordingly
· Control of incoming product:
o S5 SS Management
· Dossier Complication
· Amendment Submission
· Guidelines and Regulations
Marketing and Sales
· Brand Planning
· Customer visits with sales representative
The Affirmative Action principles as set out in the Company’s Employment Equity targets and Policy shall apply. In addition, selection of the successful candidate will be dependant on the operational requirements of the Company.
All staff interested in applying for this position should submit applications to Reina Naidoo personally or by means of email
Closing date: 08th March 2019
Job Type: Internship