QA Documentation Specialist

4 days 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

  • Document Specialist I

    1 week ago

    Midrand, South Africa Gaming Laboratories International Full time

    Providing integrity to the casino and gambling industry for over 30 years, GLI has established an incomparable team of professionals. We are looking for a Document Specialist I support our Quality Assurance team. Who We Are We have been in the gaming industry for over 30 years but pride ourselves on looking forward. GLI is on the cutting edge of casino...

  • Document Specialist I

    2 weeks ago

    Midrand, South Africa Gaming Laboratories International Full time

    Providing integrity to the casino and gambling industry for over 30 years, GLI has established an incomparable team of professionals. We are looking for a Document Specialist I support our Quality Assurance team. Who We Are We have been in the gaming industry for over 30 years but pride ourselves on looking forward. GLI is on the cutting edge of casino...

  • Spanish Speaking Document Specialist I

    1 week ago

    Midrand, South Africa Gaming Laboratories International Full time

    Providing integrity to the casino and gambling industry for over 30 years, GLI has established an incomparable team of professionals. We are looking for a Document Specialist I support our Quality Assurance team. Who We Are We have been in the gaming industry for over 30 years but pride ourselves on looking forward. GLI is on the cutting edge of casino...

  • QA Manager

    5 days ago

    Midrand, South Africa Network Contracting Full time

    **Responsibilities** - Development of a QCP by liaising with various project teams - Working with the technical and testing teams to consolidate the ITPs - Provide Quality Management supervision at end-client sites - Participate in the recruitment of Quality Management resources. - Manage the Quality Management team. - Implementation of the QMS -...

  • QA Technician

    5 days ago

    Midrand, South Africa Nandos Careers Full time

    Inspect the packaging and final product, to maintain quality of the product produced and implement all quality assurance and control processes. **Minimum Requirements**: Diploma in Food Technology, Biotechnology, or related field. HACCP, BRCGS, ERP Systems, Shopware At least a minimum 3 years in a Quality Control/ Quality Assurance role in Food...

  • Operational Documentation Specialist

    2 days ago

    Midrand, Gauteng, South Africa Adapt IT Group Full time

    Job OverviewWe are seeking a skilled individual to join our team as an Operational Documentation Specialist. This role is responsible for creating and controlling accurate company documentation, maintaining records, and ensuring the efficient operation of the Quality Management Systems.Key ResponsibilitiesEngage with Business Units to ensure that electronic...

  • Quality Assurance Pharmacist

    12 hours ago

    Midrand, South Africa Dante Personnel Full time

    Gauteng, Midrand - Monthly Cost To Company (Market related, Negotiable) Pharmaceutical company based in Midrand is seeking an experienced Quality Assurance Pharmacist to join their team **Minimum requirements**: - B. Pharm degree - Registered with the South African Pharmacy Council - Knowledge of cGxP regulations - Minimum 3 Years QA experience - SOP and...

  • Software Quality Assurance Specialist

    6 days ago

    Midrand, Gauteng, South Africa SavageOne Pty Ltd Full time

    Position OverviewWe are seeking a detail-oriented and experienced QA tester to join our team at SavageOne Pty Ltd. As an Intermediate QA tester, you will be responsible for testing software applications and ensuring they meet the highest standards of quality before release. You will collaborate closely with developers and product managers to identify and...

  • Call Centre Training Specialist

    2 weeks ago

    Midrand, South Africa Fidelity Services Group Full time

    **Overall Purpose of the Job**: We are looking for a dynamic **Training Specialist** to develop and deliver high-impact training programs in a fast-paced environment. If you have a passion for coaching, and driving business results, this is your opportunity to make a difference! **Key Responsibilities**: - Deliver **technical product, sales, objection...

  • Quality Assistant

    1 week ago

    Midrand, South Africa Neoc_People Full time

    **Responsibilities**: Assist with all QA Departmental functions as listed, but limited to: - Internal and External Audit Administration Management - SOPs and SOP Training Administration - Product Quality Review - Validations - Change Controls - Document Control (Specifications, Master Copies) - Non-Conformances - Out of Spec (OOS) - Deviations - Out of...

  • Quality Assurance Pharmacist

    12 hours ago

    Midrand, South Africa NEOC Digital Full time

    Our client is looking for a Quality Assurance Pharmacist with the responsibility to oversee all key elements of the Quality Management System (QMS) and monitor its effectiveness. The role ensures quality standards and current procedures meet regulations for GxP. The QA Pharmacist coordinates and liaise with other Departments to ensure a strong Quality...

  • Quality Assurance Pharmacist

    4 weeks ago

    Midrand, South Africa Neoc_People Full time

    PRINCIPLE DUTIES 1. QUALITY ASSURANCE: - All for the Companies various departmental SOPs reviewed, revised and updated and correctly authorised. - Manage all QA departmental functions as listed, but not limited to: - QA document control. - Site Master File. - Quality Manual and Quality Policy. - Implement the Validation Master Plan. - Approve and manage...

  • Quality Assurance Pharmacist

    7 days ago

    Midrand, South Africa Neoc_People Full time

    PRINCIPLE DUTIES 1. QUALITY ASSURANCE: - All for the Companies various departmental SOPs reviewed, revised and updated and correctly authorised. - Manage all QA departmental functions as listed, but not limited to: - QA document control. - Site Master File. - Quality Manual and Quality Policy. - Implement the Validation Master Plan. - Approve and manage...

  • Quality Assurance Pharmacist

    2 days ago

    Midrand, South Africa Full Circle Resourcing Full time

    **Quality Assurance Pharmacist - Johannesburg North - iS0QW98VR56M** **POSITION**:Permanent **COMMENCEMENT**: As soon as possible **Description**: Implement and maintain all elements needed to ensure compliance with Quality Assurance principles and systems as per regulatory, cGMP, Pharmaceutical Industry Guidelines and ISO 9000 requirements. **MINIMUM...

  • Finance & Governance Specialist (R2171)

    1 week ago

    Midrand, South Africa Mediro ICT Full time

    WHAT WILL BE YOUR ROLE AND RESPONSIBILITIES? Is responsible for the delivery of high-quality outcomes of complex and business critical activities Anticipates and integrates customer needs, strategic goals, and financial objectives Builds and maintains strategic partnerships with key decision makers internally and externally Is responsible for delivery of...

  • Tech Officer: Workshop

    3 weeks ago

    Midrand, South Africa BCXP Full time

    Business unit, Department, Reporting **Business Unit**: CPS **Department**: Field Services **Reports to**: Workshop Manager (OP1) / Ops Specialist Workshop (M6) Core Description Responsible for minor maintenance repairs and refurbishment of point of sale and various printer devices. Key Deliverables / Primary Functions **Successful completion of hardware...

  • Quality Assurance Assistant

    1 week ago

    Midrand, South Africa NEOC People Full time

    Our client is looking for a Quality Assurance Assistant who must have a deep understanding of the importance of an effective Quality Management System and has a crucial responsibility to assist in the implementation of it accordingly and to ensure it continuously meets the regulations of Good Manufacturing Practices (GMP). An effectively maintained QMS will...

  • Specialist Quality Operations

    7 days ago

    Midrand, South Africa MSD Full time

    **Position: Specialist; Quality Operations** **Grade**: P2 **Purpose of the Role**: The role is responsible for effective management of site change controls, deviations, Good Manufacturing Practice (GMP) projects, new product launches for site, site projects and supporting the batch disposition pillar. The role reports to Senior Specialist, Quality...

  • Qc Inspector

    1 week ago

    Midrand, South Africa Wood Plc Full time

    Overview / Responsibilities: Wood is currently recruiting for a QC Inspector (Level II Welding)) with experience in the oil and gas petrochemical industry to be based in Midrand. **Job Objective**: - Implement and maintain a system for the compilation and collation of a comprehensive record of construction quality documentation and certification of all...

  • Qc Inspector

    1 week ago

    Midrand, South Africa Wood Plc Full time

    Overview / Responsibilities: Wood is currently recruiting for a QC Inspector (Electrical & Instrumentation) with experience in the oil and gas petrochemical industry to be based in Midrand. **Job Objective**: - Implement and maintain a system for the compilation and collation of a comprehensive record of construction quality documentation and...