Responsible Pharmacist

Found in: Talent ZA C2 - 2 weeks ago

Midrand, South Africa Professional Resources Partners Pty Ltd Full time

Summary of position:

 

Regulatory:

Responsible for:

  • preparation of good quality dossiers and submissions according to specified timelines, in designated countries, to ensure earliest registrations and approvals.
  • preparation, review and approval of product labelling.
  • review and approval of product promotional materials.
  • management of local pharmacovigilance activities

 

Quality:

Responsible for:

  • quality oversight of activities in a defined scope (manufacturing, warehousing and distribution.
  • QC checks and release of locally manufactured products (Act 36/1947) and imported products (Act 36/1947 and Act 101/1965).quality documentation e.g., SOPs, Annual Product Reviews and Batch Manufacturing Documents.
  • self-inspections and external audits
  • assisting QA Manager in complex and external audits as required

Requirements:

  • Must have Matric / Grade 12
  • Pharm degree
  • Registered with The South African Pharmacy Council
  • Minimum 2 years Quality Assurance Management experience
  • Minimum 2 years’ experience as a Responsible Pharmacist
  • Minimum 2 years’ experience in compilation and submission of Act 101 (SAHPRA)and Act 36 (DALRRD) dossiers
  • CTD dossier format submission experience
  • Thorough understanding of GDP/GMP/GWP
  • MS Word, Excel and PowerPoint – intermediate to advanced skills required.
  • High accuracy and attention to detail skills
  • Strong work ethic

The following would enhance your position:

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

Main Accountabilities:

Regulatory:

  • Act as Deputy Responsible Pharmacist for the entity.
  • Execute Regulatory Strategy
  • Agency contact
  • Preparation and submission of dossiers
  • Maintenance & Lifecycle Management of product dossiers
  • Project Management
  • Regulatory due diligence on potential opportunities
  • Management of local Pharmacovigilance activities

Quality:

  • Operate at appropriate level of quality requirements.
  • QMS & Documentation
  • Conduct training on quality activities
  • Audits & inspections.

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