Quality Management System Pharmacist

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Date Published : 14 Aug 2018 | Category: Quality Assurance | Expiry Date: 20 Aug 2018 | Location: Clayville, Johnnesburg | Reporting to: Quality Assurance Manager

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Required Learning:

B. Pharm degree or Diploma
cGMP skills
Registration with South African Pharmacy Council
3-5 years in Pharmaceutical manufacturing environment
3-5 years in Quality Assurance

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Key Outputs :

To implement, maintain and improve the Quality Management System at Adcock Ingram Healthcare Clayville in order to ensure continuous compliance with SAHPRA and other international cGMP and Regulatory requirements.
Compile, review and approve QMS SOP’s ensuring compliance to the MCC cGMP Guidelines
Train and implement the QMS SOP’s ensuring understanding by the relevant staff
Review, track and follow through on change controls, deviations and assessing the impact of the change and non-conformance on quality systems and processes.
Review investigations arising from customer complaints, ensuring that complaints are thoroughly investigated and effective corrective and preventative actions (CAPA’s) have been identified and implemented.
Perform internal audits of departments as per schedule; compile reports and follow-up on CAPA.
Participate in risk assessments on QMS and departmental processes to assess risk and identify mitigating actions and controls.
Participate in Quality Management Reviews to identify trends in QMS processes and implement CAPAs to address any deficiencies.
Review Master Batch Documents for compliance in line with the dossier.
Review Annual PQR reports compiled and initiate CAPA’s from the recommendation of these reviews

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Core Competencies:

Attention to detail
Proactiveness
Problem solving skills
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