QA Documentation Specialist

2 months ago

Midrand, South Africa MSD Full time

The Quality Assurance Documentation Specialist is an essential role in maintaining collaboration and a high degree of accuracy to ensure compliance with Global company Data Governance and current Good Manufacuring Practice requirements. The role is responsible for management of Data governance and cGMP/cGDP documentation - Documentation Management Systems, Risk Management System, QUADS updates and Quality Council Co-ordination.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

**Primary Responsibility**:

- Manage site archiving system and ensure documents are easily retrieved, appropriately labelled, and classified and retained for the required retention periods as per the Record Retention Schedule.
- Continuous update of Electronic Document Inventory System.
- Perform periodic document recon in MIDAS, QualityDocs and e-logs.
- Routine review of documents stored offsite.
- Operate as site support for offsite storage activities.
- Operate as a Quality Council Co-ordinator.
- Responsible for compiling and maintaining site monthly Quality Council metrics reports and updating QUADS.
- Operate as Site System/Topic Owner, main contact point and Subject Matter Expert for site Data governance and cGMP/GDP documentation.
- Run, review, and distribute Standard Operating Procedures (SOP) Periodic Review Reports.
- Initiate SOP Periodic Review Workflows.
- Provide guidance during SOP update pre-consultation Meetings.
- Support site as Quality Risk Management Site Champion.
- Responsible for logging of Quality Risk Management Plans.
- Review and update Risk Register in Risk Management System.
- Conduct Site Quality Risk Management Committee meetings.
- Ensure relevant training and access linked to QualityDocs, RMS and QUADS are assigned to relevant new employees impacted by the systems.
- Compile Annual Health Assessment for the allocated topics and close any gaps identified in a timely manner to ensure site compliance.
- Participation in global Community of Practice discussions.
- Lead change and process improvement initiatives related to Data governance and CGMP/CGDP documentation.

**Education**:

- An accredited Diploma or Degree in natural or health sciences.

**Experience**:

- Minimum 3-5 years’ applied experience in Quality Assurance/Systems/Operations/Control within the pharmaceutical environment.
- Advanced experience in working with MS Word, Excel, PowerPoint, and MS outlook is preferred.
- Working knowledge in Quality Risk Management Tools and principles.
- Knowledge and strong understanding of Health Authorities regulatory requirements and compliance/quality requirements is an advantage.

**Skills**:

- Strong attention to detail and analytical thinking.
- Ability to collaborate with cross-functional teams.
- Effective communication, writing and presentation skills.
- Time Management.
- Planning and Organizational skills.

**Behavioural Attributes**
- Results driven
- Innovative
- Collaborative
- Proactive

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

**Who we are**

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

**What we look for**

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue **Inventing For Life, Impacting Lives** while **Inspiring Your Career Growth**.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking a

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