QA Manager

2 weeks ago

Epping, Western Cape, South Africa Aspen Pharma Group Full time

BASIC JOB FUNCTIONS (Brief Summary)

  • Ensure compliance with manufacturing QS requirements and procedures
  • Batch release requirements are adhered to and performed in line with OTIF and planning schedule.
  • Compliance and effectiveness of the QMS is regularly assessed
  • To ensure legal compliance to all Acts, i.e. the Pharmacy Act (Act No 53 of 1974, as amended) and the Medicines and Related Substance Control Act (Act 101 of 1965, as amended)
  • To carry out the duties of a Responsible Pharmacist in accordance with Regulations 28 of the Pharmacy Act
  • To act responsibly in the practice of pharmacist in accordance with operational requirements of the business
  • Initiate, compose, implement and regularly update SOP's relating to above.
  • Ensure that Vendor Management systems are in place.
  • Develop KPIs and priorities for the section and direct reports.
  • Product and Quality problems are dealt with effectively. Prevent and minimize recurrence of such failures.
  • Manage customer and Regulatory Inspections.
  • Train appropriate personnel in SOP's and other relevant areas

PERSONAL ATTRIBUTES (Brief Summary)

  • Good organizational skills and deadline driven.
  • Exceptional attention to detail and accuracy.
  • Good communication (written and verbal) with report writing and document reviewing skills.
  • Uncompromising individual integrity and work ethic.
  • Ability to communicate effectively at all business levels.
  • Proven leadership skills, selfdriven and motivated.
  • Interrogating Information?
  • Managing Performance?
  • Offering Insights?
  • Taking Action?
  • Investigating Possibilities

JOB SPECIFICATIONS:

  • Registered with the Pharmacy Council
  • Minimum 5years of Manufacturing Distribution and or packaging of pharmaceutical products and Quality experience or a combination thereof.
  • Minimum requirement BPharm, degree or equivalent as per the National Qualifications Framework
  • Product registration experience (advantage)
  • Lead auditor qualification.
  • Computer literate able to use MS Word, Excel, Access, Sharepoint (advantage)

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