Quality Systems Manager

2 weeks ago

Johannesburg, South Africa Neoc_People Full time

**As a Systems Manager, you are required to**:

- Proactively monitor the various elements of the QMS to help ensure compliance with quality system regulations and applicable standards.
- Oversee the companys Document Management System (ZenQMS) including the review and approval of procedures; ensuring that all company procedures and forms are kept in a valid status and are revised, as well as ensuring that process flows are updated in the background of the software.
- Ensure alignment of company Quality Manual with business needs, regulators and industry standards and an up-to-date Site Master File.
- Oversee the Annual Product Quality Reviews (APQRs) ensuring completion thereof per schedule by the Quality Systems Officers.
- Oversee the stability program, ensuring that it is maintained in accordance with company and local health authority requirements.
- Ensure e-Compliance GMP and regulatory compliance within site including the review and approval of GMP documents related to Computer System Validation (CSV), electronic records and signatures, changes, deviations.
- Oversee the control and approval of all activities related to CSV, electronic records and signatures, in order to ensure GxP compliant implementation and maintenance of automated systems (PCS) and Software-Applications (IT Systems).
- Oversee QA review of data (paper or electronic) to establish adherence to Good Documentation Principles throughout the data lifecycle as the data is created, reviewed, modified, maintained, retrieved, processed, transferred, etc.
- Support and monitor the FMEA process on site.
- Perform QA approval on OOSs, CAPAs and deviations when required.- Support in achieving site KQIS monthly.
- Oversee quality assurance approval of quality control specifications and methods.
- Support the preparation and follow-up of inspections by Health Authorities and customers and participate in Self Inspections and ensure follow-up.
- Initiate and implement quality improvement projects.
- Continuously review WHO, PICS and SAHPRA guidelines, and perform gap assessments versus current site procedures.
- Support Med-Tech activities as required.

**You bring with you**
- A minimum of 5 years experience in quality, validation or related departments within a Pharmaceutical Manufacturing environment.
- A minimum of 5 years management experience.
- Demonstrated knowledge of quality systems.
- A thorough understanding of the relevant regulations, standards, and operating procedures.
- An understanding of quality concepts such as: documentation systems, change control and electronic records.
- Ability to work well cross-functionally and can interpret the requirements as well as educate and influence others on those requirements.
- Information gathering and processing skills.
- Technical reporting and Project Planning skills.
- Excellent computer skills and understanding of e-compliance.

**You will need**:

- Pharm, B.Sc. Pharmacy, M.Sc Chemistry or equivalent degree.
- Proficiency in SAP and MS Office suite.

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