Responsible Pharmacist

2 weeks ago


Johannesburg, Gauteng, South Africa ES Recruitment 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 labeling.
- 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:


  • Must have a B

Pharm degree:
-
Registered with The South African Pharmacy Council:


  • Minimum 2 years of 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 the appropriate level of quality requirements
  • QMS & Documentation
  • Conduct training on quality activities
  • Audits & inspections.


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