Job Description

THE JOB AT A GLANCE

• As the Quality Assurance Pharmacist/Deputy Responsible Pharmacist you are to perform the duties as contemplated in Regulation 23 (3) of the Pharmacy Act No 53 of 1974 and the relevant sections of the Medicines and Related Substances Act, No 101 of 1965.  You will ensure that product released for sale will at all times comply to standard operating practices as set out in the site master file and quality manual.

Responsibilities

WHAT YOU WILL DO

• Deputise for the responsible pharmacist during his/her absence.
• Be responsible for quality assurance and form an integral part of the decision-making process in all areas affecting the quality of the product.
• Implement the quality management system through continuous monitoring and improving of the system within Tiger Brands as well as at contract packers in line with regulatory guidelines.
• Assist the responsible pharmacist in co-ordinating the recall activities as per regulatory requirements, SAHPRA guidelines and company procedures.
• Be responsible for final product approval of product before release of product for resale to market after QC approval by approved manufacturer or laboratory by ensuring all batch documentation complies to master documentation.
• Review, implement and/or update the necessary SOPs and processes to allow optimal departmental functioning consistent with current practices and regulatory requirements.
• Implement, review and document adequate and appropriate training of all staff on relevant SOPs. Review changes to legislation and update SOPs accordingly
• Handle all product complaints and adverse events according to regulatory requirements.
• Review and update site master file in line with SAHPRA guidelines
• Carry out annual product quality reviews as per SAHPRA guidelines
• Attend and participate in all SAHPRA and other regulatory audits.
• Liaise with QA pharmacists at contract manufacturers to ensure integrity and quality of released product.

Qualifications

WHAT YOU’LL BRING TO THE TABLE

Key attributes and competencies

• Strong sense of quality- intolerant to mediocrity and compromise on product integrity
• Sound knowledge of SAHPRA policies and procedures– Full understanding of the Act and its application within our business
• Computer Literacy – Comfort working across Microsoft suite and Tiger systems
• Detail Oriented – Ability to dive into detail and commitment to complete tasks

Experience

• Relevant tertiary degree in Pharmacy
• Registration with SA Pharmacy council
• Internship in manufacturing required
• Experience in quality assurance essential

WHAT YOU WILL BE MEASURED ON

• Timeous release of products as per SLA with supply chain
• Audit of 3rd party contract manufactures and implementation of corrective actions
• Compliance of internal and external staff and site with requirements of South African Pharmacy Council and SAHPRA.