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Responsible Pharmacist

Responsible Pharmacist

Professional Resources Partners Pty LtdMidrand, Gauteng, South Africa
1 day ago
Job description

Summary of Position

Regulatory :

Regulatory Responsibilities

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 Responsibilities

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 : Responsible for :

  • QMS & Documentation
  • Conduct training on quality activities
  • Audits & inspections.
  • #J-18808-Ljbffr

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    Pharmacist • Midrand, Gauteng, South Africa

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