Responsible Pharmacist & Quality Assurance Manager at Kasha Global

Job purpose:

Responsible for Kasha complying with the South Africa Health Products Regulatory Authority (SAHPRA) and South African Pharmacy Council (SAPC). The incumbent will also set up Kasha Retail and Wholesale Pharmacy in South Africa, and develop & execute its strategies for success. Act as the single point of contact (SPOC) for internal and external business partners with regard to:

• Communication with South African Regulatory Authorities (BoH) i.e. SAHPRA, SAPC, and the National Department of Health (NDoH). 
• Country/Region Specific Quality System mandates and requirements. 
• The cross-functional team where technical expertise is needed.

N.B: An assignment may form part of the selection process.

Job Responsibilities:

• To lead Quality Systems for Kasha Technologies products marketed in South Africa.
• Be the leadership team contact for Quality Assurance and Quality related issues for Kasha Technologies in South Africa. Timely sharing of quality issues that have a potential impact on compliance or business with key stakeholders as per corporate policies and procedures.
• To define, update, and maintain the Quality Management System of the Kasha Technologies South Africa Subsidiary, to meet internal and external compliance for Kasha Technologies products marketed in the Country/Region.
• Reporting & documenting quality events/deviations. Ensure timely closure of documentation completion with respect to investigation and action plan.
• To secure implementation of local legislation and Kasha Technologies global standards.
• Maintain Country/Region Scorecard, lead review & quality improvement plans. 
• Report/escalate non-conformities and departures from quality agreements in a timely manner.
• To approve & review requests for changes and provide needed inputs to change controls for country-specific changes. 
• To review organizational requirements with respect to resources.
• Ensure that an adequate Quality Training System is in place for the Kasha team in the Country/Region.
• To proactively cooperate with internal and external interfaces (cross-functional and cross-region) for issues that impact across regions and multi-functional discussions.
• To assure inspection readiness of regional quality activities and coordinate and follow-up health authority inspections.
• Timely Response to any BoH/FDA query letters to ensure action plan compliance.
• Ensure pharmacovigilance systems & interfaces are aligned within the Country/Region. Have oversight over the agreement with the third-party provider performing this function and ensure that regulatory updates are shared with service providers by the person(s) responsible for local regulatory intelligence.
• Support Initiatives & launches in the Country/Region by providing inputs on technical readiness, validation /document reviews (where required), compliance, and quality risk.
• Coordinate and review Quality Technical Agreements (QATAs) for all outsourced activities relating to the manufacture, storage, and distribution of all Kasha Technologies products for domestic and export markets, as applicable.
• Manage the process of release for sale for Kasha Technologies Finished Products in accordance with corporate standards and local regulatory requirements. 
• Lead customer and consumer complaints data review, investigation, and action plan as applicable.
• Ensure conformance to applicable Good Distribution Practices rules in the region (warehousing and both incoming and outgoing shipments) with customers and third-party logistics (3PL) (as applicable).
• Work closely with 3PL QA, and Kasha Product Supply Team by supporting external and internal audit & action plans in addition to capability building & coaching when needed.
• Ensure audit readiness and manage audit action plan closure for any site audits performed by corporate QA auditors or external regulators.
• Be part of the decision-making processes affecting pharmacy business and quality assurance.
• Supervise over any pharmacists appointed by the owner of the Pharmacy and ensure that the Pharmacy Owner complies with the conditions of ownership and registration of a pharmacy business.
• Appointment of a Deputy Responsible Pharmacist (DRP) and ensuring delegation of authority to the DRP in his/her absence.
• Compile/maintain letters for all activities delegated, initiate and coordinate all product recall activities as per corporate standards and local regulatory requirements.
• Ensure that ongoing product stability and product quality reviews are being done.
• Management and coaching of all direct reports, ensuring that they only perform acts that fall in line with the scope of practice of the pharmacy.

Role Requirements:

•  Bachelor of Pharmacy Degree from an accredited institution. A master's degree in a health-related field will be an added advantage.
• Minimum of 5 years experience in the Pharma Industry as a Responsible Pharmacist. 
• Must be licensed to work as a pharmacist and be in good standing with the South African Pharmacy Council.
• Minimum 5 years of related experience within the field of Quality Assurance and GMP/GDP-regulated environment.
• Demonstrated working knowledge of principles and concepts of Quality Assurance, including those related to risk-based approach and quality design (ICH Q8 – Q12).
• Demonstrate a working knowledge of ISO 9001, ISO 13485, and PICS guidelines.
• Adequate technical expertise in the Quality Assurance field.
• Good Interpersonal skills including good leadership and communication skills with internal and external business partners.