Job Purpose

• To ensure that Cipla SSA operates in compliance with Cipla’s Quality Management System requirements, Regulations in the respective SSA countries, in-country guidelines as well as Good Practice guidance documents pertaining to manufacture, warehousing and distribution of medicines and other health related products.
• To centrally support and perform SSA QA activities for all SSA countries from the Cipla Kenya office with regards to Vendor management (QTA’s, site audits, site approval), QA technical query resolution, audits and general QA support.

Accountabilities

• Implements and manages Quality Management System (QMS) for Cipla in the SSA territories.
• Manages all Quality related activities with the respective in-country warehouses and distributors.
• Review and escalation of Non-conformances (NC), Deviations and Out of Specification/Trend (OOS/OOT) notifications impacting SSA supply.
• Co-ordination of QA Product Complaints/ Technical Queries
• SSA vendor Management
• Quality Technical Agreement (QTA)
• Audit readiness by ensuring Cipla Kenya’s QMS is compliant to relevant acts and standards including.
• Product Recall by coordinating all recall activities for all SSA countries and acting as SPOC between MAH, distributor and respective Cipla teams.
• Supports Quality Operations Director SS Assists with any reasonable duties as requested by SSA QA management to ensure that the department is functioning optimally and meeting its set objectives and goals.

Requirements

Education Qualification

• Bachelor’s degree in pharmacy
• Additional business diploma / degree is an added advantage.
• Computer skills – MS Word, MS Excel both at Intermediate level and higher.

Relevant Work Experience

• At least 3 years’ work experience in a pharmaceutical company or similar background.
• Experience in Quality Assurance is required.
• Experience in performing audits is required.
• Experience in a pharmaceutical wholesale/ warehouse would be beneficial.

Competencies and Skills

• High level of written and verbal communication ability in English.
• High level of accuracy and attention to detail.
• Ability to cope under pressure, stress, high volume workload and adhere to strict deadlines.