VACANT POSITION - QC Specialist (Deputy Responsible Pharmacist)

Ceva Animal Health (Pty) Ltd is looking for a qualified Pharmacist to take the role of our QC Specialist / Pharmacist position. This person will also be the Deputy Responsible Pharmacist of the Company.

Summary of position:

  • At local level, provide and ensure the quality oversight of activities in a defined scope (manufacturing, warehousing, and releasing of locally manufactured products registered under Act 36 of 1947).
  • Perform QA checks and release of imported products registered under Act 36 of 1947 and Act 101 of 1965.
  • Be responsible for Quality documentation, e.g., SOPs, Annual Product Reviews.
  • At local level, conduct internal audits of the activities and manage projects as appropriate.
  • Assist QA Manager as auditor for complex / external audits.

 Requirements:

  • Matric / Grade 12
  • B. Pharm degree
  • Registered with the SA Pharmacy Council
  • Quality Assurance experience will be an advantage (2-3 years)
  • Thorough understanding of GDP/GMP
  • High accuracy and attention to detail skills
  • Strong work ethic.

The following would enhance your application:

  • GDP / GMP Training / Certificate
  • Animal Health Industry experience
  • Knowledge of regulatory submissions in Botswana, Namibia, Zambia and Zimbabwe.
  • Pharmaceutical production knowledge.

Main Accountabilities:

1.     Act as Deputy Responsible Pharmacist for the entity

2.     At appropriate level of Quality & Strategy:

  •  Implement and improve the quality system.
  •  Release non-GMP/GMP products and materials (including investigational products).
  • Be accountable for quality-related decisions (depending on seniority level).
  • Manage product-related deviation, change control and action plan processes
  • Complete assigned CAPA, change control or any other assigned actions according to target dates.
  • Be responsible for pharmacovigilance (product complaints and adverse drug events).
  • Be responsible for the stability program.

 3.     QMS

  • Write QMS documents
  • Approve SOPs as applicable.

 4.     Community Building & activation

  • Ensure continuous improvement in the production processes in conjunction with other departments.
  • Build training modules and present Quality training sessions.

 5.     Audits & inspections

  • Assist with external audits as required (contract research sites, laboratories and manufacturers).
  • Assist with internal audits as appropriate.
  • Conduct self-inspections
  • Possibly host inspections.

Technical Skills required:

  • Previous audit experience
  • Technical and scientific knowledge
  • Continuous improvement of processes
  • Regulations’ knowledge
  • Quality Management Systems knowledge
  • Strong MS Office and IT tools skills
  • Ability to anticipate and solve problems and queries.

Closing date for applications:  17 June 2022

Fax or e-mail applications to:

Contact:  Elzet Rusch

E-mail:  elzet.rusch@ceva.com

Last update: 07/06/2022

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