Responsible Pharmacist

3 weeks ago

Centurion, South Africa Dante Personnel Full time

Gauteng, Centurion
- R763 200 ctc per annum (Negotiable)

Our global pharmaceutical client based in Centurion is looking for a Responsible Pharmacist to join their dynamic team

**Main purpose of the role**:

- Responsible to comply with all the duties of a Responsible Pharmacist contemplated in regulation 25(3) of the Pharmacy Act and the relevant sections of the Medicines Act and as specified in the Company's SOP relating to the duties of the Responsible Pharmacist
- Responsible for the 100% compliance of the business in terms of the above
- Oversee Regulatory Affairs, Pharmacovigilance, and Quality Assurance supported by the relevant managers for the company and continuously supervise the Pharmacy
- Liaising with SAHPRA, SAPC, DOH, and Regulatory Personnel from other Companies and Principals

**Minimum requirements**:

- Required B. Pharm Degree (Registered Pharmacist)
- 5 Years' experience as a Pharmacist in a generic pharmaceutical or similar environment
- Able to analyze market data
- Sound financial understanding
- Sound knowledge of MS Office (Excel, Word, PowerPoint, and Outlook)
- Attention to detail
- Good interpersonal skills
- Disciplined
- Assertive and Pro-Active
- Ability to work under pressure
- Forward-thinking
- Proactive detail-orientated and organized
- Analytical and interpretation
- Prioritise workload to tight deadlines
- Innovative, problem-solving, and decision-making skills
- Ability to set standards and objectives and monitor progress
- Ability to manage and motivate professional people
- Good communication and interpersonal skills
- Cross-functional ability
- Must be able to work outside office hours when required or requested to do so
- From time-to-time, be required to undertake alternative or additional duties suitable to your experience and skills level

**Travel**:

- Local - Weekly if needed (SAHPRA, Conferences, Congresses, Training)
- Regional - If needed
- International - Annually and/or as required

**KPI Quality Standards**:

- Monthly compiling and presentation of Management Reports, feedback on Regulatory; Pharmacovigilance, Quality, and Med-Info
- Annual presentation of the Quality Management Review
- Responsible for maintaining SAHPRA, DOH, and SAPC Licenses
- Launch readiness new products
- Artwork approvals for printed packaging materials
- Self-inspections
- Regulatory-related SOP maintenance
- Change controls where regulatory relevant
- Presentation of Regulatory and Pharmacovigilance feedback at managers' meetings
- Accurate and timeous submission of new Regulatory dossiers and responses to SAHPRA
- Accurate and timeous submission of amendments to registered products dossiers and relevant responses to SAHPRA
- Assist with regulatory parts for accurate and timeous completion of Annual Product Reviews (APRs)
- Annual Staff Training (Reps and Office Staff) on Regulatory and Pharmacovigilance issues
- Advertising material approvals
- Post-importation testing readiness
- Technical Complaints, Deviations and CAPAs, and Trending
- Change controls
- Annual Product Quality Reviews
- Artwork approvals
- QA-Related SOP Maintenance
- Change Control approvals where QA-Relevant

**Key Performance Areas**:

- **General**:

- Responsible Pharmacist role to ensure 100% compliance in terms of GMP and all SAPC, SAHPRA, and DOH requirements and ensure all licenses are current
- Continuously supervise the pharmacy and duly delegate the responsibility
- RA: QA and PV Budget maintenance
- Oversee and assist with medication Import and Export and INCB (Controlled substance) Permits and annual returns, and quarterly status updates to SAHPRA
- Staff Training (Sales and Office), where applicable, on relevant SOPs and Regulatory/GMP Regulations
- Product Related Information sourcing and MEDINFO Documentation
- Problem-solving regarding Stock Releases Issues (QA) or Dossier related challenges (RA)
- Ensure Regulatory and Pharmacovigilance Agreements are in place with all 3rd Party Suppliers and that it is maintained, implemented, and revised regularly
- **Regulatory**:

- Oversee the registration process of new products (pipeline management)
- Oversee registration maintenance of registered products (compliance)
- Responsible for Advertising/marketing approvals
- Approval of printing packaging materials
- Annual Product Reviews, including Regulatory and Follow-Up Stability Data
- Regulatory SOPs maintenance
- Ensuring that Section 21 Regulations are adhered to, if and where applicable
- Change controls that are Regulatory-relevant from the Principal and initiate local regulatory change controls
- **Quality Assurance**:

- Coordinate and approve 3rd Party Technical Quality Agreements
- Control and assist with Technical Complaints, customer returns, and rejections
- Responsible for Audit Schedule maintenance and Vendor Audits (Manufacturer, Packers, Third Party Distributors, and Laboratories)
- Responsible for conducting timeous self-inspections
- Responsible for post-importation testing rea

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