Specialist Quality Operations

1 week 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 Operations.

**Primary Responsibilities**:
**Management of the Change Control and Deviation platforms for the operating site, as follows**:

- Operates as the main contact point and SME [Subject Matter Expert] for site
- Execution of administrative responsibilities associated with the electronic platforms.
- Assisting in guiding users and troubleshooting issues with the electronic platforms for deviations and change controls.
- Training and qualification of new users
- Periodic trend analysis and status oversight change controls and deviations as required by global MSD procedures
- Identification of site change owners for global and regional change controls impacting site as well as being change owner for QA change controls.
- Ensure that Organon change controls are implemented in a timely manner at MSD site.
- Management of the quality metrics for change control and deviations as per global requirements and process lifecycle.
- Participation in global Community of Practice discussions.
- Acts as topic lead for deviations and change controls for the site.
- Prepare and lead monthly change review board meeting for site.
- Perform annual health assessments for QMS topics related to deviations and change controls - Close any gaps identified in a timely manner to ensure site compliance.
- Responsible for deviation and change controls systems compliance status during internal and external GMP audits.
- Support the batch disposition pillar as the site deviation classification assessor, by actively engaging with the responsible departments for effective troubleshooting and adhering to global timelines for deviation phases.

**Management of new product launches for site, for fully imported product**:

- Participate in new product launch site and global meetings.
- Engage with site stakeholders in determining timelines as tasks.
- Gather product registration information from local Regulatory Affairs, where applicable.
- Management of site change controls for new product launches - where applicable
- Identify site task owners as per change requirements.

**Site Projects**
- Represent Quality end to end on all site projects.

**Additional Support responsibilities**
- Support packaging component release, retention sample management, and product release pillar.

**Education**:

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

**Experience**:

- Minimum 3-5 years’ experience in Quality Assurance/Systems/Operations/Control within pharmaceutical environment
- Experience with automated systems for the management of Deviations and Change Controls is preferred.
- Experience in project management and process implementation is preferred.
- Knowledge of GMP regulatory requirements is an advantage

**Skills**:

- Must have good Microsoft Word, Excel, and Power Point skills.
- Strong attention to details and analytical thinking capabilities
- Ability to collaborate with cross-functional teams
- Supervisory skills
- Effective communication and writing skills

**Behavioral Attributes**
- Agility
- Results driven
- Innovative
- Collaborative
- Proactive

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R210046



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