Job Purpose

• To ensure that Cipla Medpro operates in compliance with Cipla’s Quality Management System requirements, all of the provisions of Act 101 of 1965 (Medicine and Related Substances Control Act), Act 53 of 1973 (Pharmacy Act) and all Regulations to these Acts, guidelines as well as Good Practice guidance documents pertaining to manufacture, warehousing and distribution of medicines and other health related products.
• To review Non-conformance reports, Deviation Requests, Out of Specification (OOS)/ Out of Trend (OOT), Out of Action Levels (OOAC) and Out of Alert Level (OOAL) investigations and subsequent correspondence thereof, and drive these to closure timeously.
• To review and drive CAPAs when they are raised internally, as well as those raised as a result of Non-conformances and driving these to closure.
• To Act as the ISO13485 SPOC and subject matter expert for the business.
• To oversee and/or provide job-specific QA training to QA personnel.
• To provide Tier 1 Administrator support on the Learning Management System (LMS).
• To support audit readiness by performing Self-Inspections on QMS processes and conduct Internal Audits as per the Audit Schedules.
• Ensure the opportunities for improvements are actioned by facilitating the Continual Improvement process in the QA Department.

Accountabilities

• Review and approval of Non-conformances (NC)/ Deviations, Out of Specification (OOS)/ Out of Trend (OOT), Out of Action Levels (OOAC) and Out of Alert Level (OOAL) investigations
• Quality Management System (QMS) & SOPs
• Continual Improvement
• Internal training via Learning Management System (LMS)
• Internal Audits
• Supporting personnel compliances and cross functional and stakeholder relationships for enhancing performance of QA team
• Projects, General Administration and Support
• Pharmacovigilance
• Product Quality Review (PQR)
• Stability
• Temperature Excursions
• ISO 13485:2016 Implementation
• Risk Assessments
• Business Acquisitions

Education Qualification

• Bachelors degree in a science or technology field (B.Sc/ B.Tech), or other relevant qualification e.g. Diploma in Quality Management
• Computer skills – MS Word, MS Excel both at Intermediate Level.
• Ability to navigate unassisted through QMS Sharepoint systems and databases.

Relevant Work Experience

• At least 5 years’ work experience in Quality Assurance, preferably in a pharmaceutical company or similar background.