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SOUTH AFRICAN NUCLEAR ENERGY CORPORATION (NECSA)
 
COMPANY: Ketlaphela Pharmaceuticals SOC Ltd
DEPARTMENT: Regulatory 
VACANCY: Responsible Pharmacist 
SALARY BAND: Up to D3P
STATUS: Permanent position
REF NO: EC15593
 
Ketlaphela Pharmaceutical SOC Ltd ‘‘Ketlaphela’’ is a wholly owned subsidiary of Pelchem SOC Ltd and part of the NECSA Group. As a state owned pharmaceutical company, Ketlaphela was established to improve the security of supply for the burden of diseases by locally manufacturing the main active ingredients in South Africa.
 
Job Profile:
Full responsibility as the Responsible Pharmacist, in accordance with legal and statutory requirements of SA Pharmacy Council (SAPC), South African Health Products Regulatory Authority (SAPHRA) and Department of Health (DOH). 
 
 
Key Performance Areas
Regulatory and Quality 
  • Perform all duties as legally required by Medicine and Related Substances Act 101 of 1965 and the Pharmacy Act 53 of 1974 (as amended), for Ketlaphela Pharmaceuticals SOC Ltd and compliance to GMP/PIC/WHO guidelines; OSH Act.
  • Accountable for medicine registration dossiers for the South African market including updates and amendments (Variations).
  • Compiling of applications to SAHPRA for Manufacturing Licenses.
  • Manage, co-ordinate and approve new and updated printed packaging and advertising materials for compliance with regulations.
  • Maintain databases of all SAHPRA /SAPC/ DOH (SEP if applicable) related documents;
  • Accountable for cGMP (Current Good Manufacturing Practice) within Ketlaphela (implementation and maintenance of cGMP).
  • Evaluation of Ketlaphela’s QMS to ensure that cGMP and QMS is reconcilable.
  • Manage and co-ordinate the creation, update and approval of master documentation.
  • Involved in planning of business activities for Ketlaphela. Be part of decision making processes (attendance of management meetings).
  • Responsible for the co-ordination of the approved suppliers list for active -, inactive raw materials and direct packing materials of final and intermediate products.
  • Provision of pharmaceutical product information to internal and external customers in collaboration with marketing.
  • Provide support to other staff members of Ketlaphela regarding pharmaceutical issues;
  • Management of pharmacovigilance (including product recalls).
  • Involved in audits and inspections carried out by SAHPRA and SAPC.
  • Identifying needs/ resources for facility and processes.
  • Liaison with SAHPRA, SAPC and DOH (SEP if applicable).
  • Involved in Customer complaints, deviations and Non conformities (acceptance, recommendations for corrections, corrective actions and investigations).
  • Involved in developmental activities for new products or processes.
  • Involved in informal training of staff regarding cGMP, accountable for formal training of staff.
  • Supplying information for budget purposes with respect to RP/ regulatory activities.
  • Accountable for evaluation of systems, apparatus and validation reports.
  • Provides patent, trademark and competitive product intelligence.
 
Job Specific and Behavioral skills:
  • Portfolio Management
  • Project Management
  • Negotiation skills are essential
  • Ability to work in a team environment and ability to handle pressure in meeting tight timelines
  • Maintains confidentiality, privacy and security of information
  • Analytical thinking and attention to detail. 
  • Judgement and decision making. 
  • Excellence and quality orientation. 
  • Proactive 
  • Approachable 
  • Performance driven 
  • Integrity 
  • Decisive 
  • Assertiveness 
  • Excellent report writing skills. 
  • Willingness to transfer skills and knowledge amongst colleagues 
 
Qualifications and Experience:
  • B. Pharm degree.
  • Registered with South African Pharmacy Council as a practicing Pharmacist.
  • A minimum of 5 years’ experience as a registered Responsible Pharmacist; and
  • A minimum of 5 years’ in regulatory role with manufacturing/distribution background. 
 

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Closing date: 12 May 2021.
 
Ms. Tsireledzo Rakhalaru
Tel: 012 305 4177
Building: Beva E3/E4
Room: 3205D (Third floor)
 
Please forward your updated CV with certified copies of your educational qualifications to Tsireledzo.Rakhalaru@pelchem.co.za
 
GENERAL:
The appointment of a candidate is subject to the outcome of medical and security checks. The suitable candidate will be selected with the intention of promoting diversity and achieving EE targets as contemplated in the relevant Pelchem Employment Equity Plan.
Pelchem is a member of the Necsa Group.   
 
The company strives to improve our employment equity targets. Should you not hear from us within 30 days of the closing date, please consider your application unsuccessful.