Quality Systems and Compliance Specialist

2 weeks ago

Midrand, South Africa MSD Full time

**Specialist, Quality Systems & Compliance**

The Quality Systems & Compliance Specialist is responsible for assisting in enhancing Quality Systems by taking responsibility and being accountable for the responsibilities listed below. The responsibilities must comply with quality standards, processes and specifications in line with registered information, local and global GMP requirements.

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 Responsibilities:_**
- QMS Topic Owner for PQR, Customer Complaints and Quality Agreement.
- Management and oversight of PQRs (PQR Data collection, Drafting of Product Quality Review reports, technical review of completed PQR reports and ensuring that PQR timelines are strictly adhered to).
- Management and oversight of product complaints in line with local and global procedures.
- Management and review all Quality Agreements between the company and respective Contract Acceptors/Givers.
- Author and approval of site SOPs relevant to QMS workstreams - where applicable
- Participation in Community of Practice meetings/discussion on QMS workstreams
- Management and maintenance of QMS mailbox for global Quality Directives and QMS updates.
- Management of the electronic reporting of the implementation of directives and updates.
- Contribution to Quality Council and ensuring that monthly metrics are supplied.
- Support development and implementation of DI Global Procedure. Participation in deviation classifications and investigations, Quality Risk Management and Change Control Systems.
- Participation in Health Authority and Global quality audits.
- Participate in and lead [as required] meetings, problem solving sessions and strategy development plans with company representatives for which our Company operates as a Contract Manufacturing Organization.

**_ Education_**
- Minimum tertiary degree/Diploma in Science (BSc), Pharmacy or related field.

**_
- **_Experience_**
- At least** 2-3 years’ **experience in the pharmaceutical industry.
- Understanding of GMP particularly with reference to packing operations.
- Knowledge of Global and SAHPRA regulatory requirements.
- Proficiency in Microsoft Word and Excel software.
- Experience in the Quality Assurance pillar.

**_ Skills_**
- Assertive and a very strong communicator who can develop contacts on-site and with external network.
- High Technical Skill.
- Attention to detail.
- Problem solving skills (ability to identify risks/gaps, assess the impact and recommend actions for correction).
- Good oral and written communication skills.
- A high degree of accuracy is required to ensure compliance with the Company's quality systems.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Not Applicable

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R288549

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