Quality Systems and Compliance Specialist
7 months ago
**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
-
Fire Detection Systems Specialist
1 month ago
Midrand, Gauteng, South Africa OTN Systems South-Africa Full timeAt OTN Systems South-Africa, we are seeking a highly skilled Fire Detection Systems Specialist to join our team.About the RoleThis is a challenging and rewarding opportunity for an individual with a strong background in fire detection technologies, industry standards, and regulatory requirements. As a Fire Detection Systems Specialist, you will be...
-
Compliance Specialist
2 days ago
Midrand, Gauteng, South Africa The Recruitment Council Full timeJob Description:The Recruitment Council is seeking a highly skilled Compliance Specialist to join our team. This position reports to the Head of Compliance and involves ensuring adherence to relevant legislative regulations and maintaining quality assurance in our clients' offices, covering long-term and short-term assurance, collective investments, and...
-
Senior Quality Specialist
6 months ago
Midrand, South Africa DSM Full time**Job title - Senior Quality Specialist** **Location - **Midrand**, South Africa** **Job model - On Site/Hybrid** DSM-Firmenich are recruiting a Senior Quality Specialist who is responsible for independently supporting the site team to achieve quality performance and compliance within a key strategic site within dsm-firmenich. At dsm-firmenich, being a...
-
Quality Assurance Specialist
3 weeks ago
Midrand, Gauteng, South Africa Express Employment Professionals Midrand Full timeJob Description: We are seeking an experienced Quality Assurance Specialist to join our team at Express Employment Professionals Midrand. The ideal candidate will have a proven track record of ensuring quality control processes are in place and maintained.About the Role: This is a critical position that requires attention to detail, analytical skills, and...
-
Regulatory Compliance Specialist
2 days ago
Midrand, Gauteng, South Africa The Recruitment Council Full timeJob DescriptionWe are seeking a highly skilled Regulatory Compliance Specialist to join our team at The Recruitment Council.Estimated Salary: $85,000 - $110,000 per annumResponsibilitiesThe successful candidate will be responsible for ensuring adherence to relevant legislative regulations and maintaining quality assurance in our offices. Key responsibilities...
-
Spec: Standards, Quality and Compliance
6 months ago
Midrand, South Africa BCXP Full timeBusiness Unit, Department, Reporting Job grade/Level S5 Business Unit Digital Platform Solutions Department Octane Position reports to Executive: Octane Span of Control None Level of Engagement Internal and External stakeholders Core Description Responsible to develop, enhance and manage the SABS 1020, SANS 10378 and NRCS (National Regulator for compulsory...
-
IT Governance, Risk and Compliance Specialist
7 months ago
Midrand, South Africa Thamani Technology Systems Full time**Full job description** **Key Responsibilities**: - Gain a deep understanding of local regulations and requirements set forth by central banks, financial authorities, and other stakeholders. - Translate regulatory requirements into actionable plans and initiatives, collaborating with relevant teams to ensure timely implementation. - Monitor progress on...
-
Aircraft Manufacturing Specialist
4 weeks ago
Midrand, Gauteng, South Africa Paramount Aerospace Systems Full time**Job Overview:**We are seeking an experienced Aircraft Manufacturing Specialist to join our team at Paramount Aerospace Systems. In this role, you will be responsible for manufacturing and assembling aircraft parts, ensuring high-quality standards and meeting project deadlines.**Key Responsibilities:* Consults technical drawings, work orders, and schematics...
-
Lead Security Systems Specialist
3 weeks ago
Midrand, Gauteng, South Africa Bidvest Protea Coin Full timeJob Title: Lead Security Systems SpecialistWe are seeking an experienced and skilled Lead Security Systems Specialist to join our team at Bidvest Protea Coin in Midrand.Company OverviewBidvest Protea Coin is a reputable company committed to delivering exceptional services in the security industry. As a Lead Security Systems Specialist, you will play a...
-
Specialist: Governance and Compliance
7 months ago
Midrand, South Africa Nexio Full time**ROLE PURPOSE** Nexio is a specialist ICT solution provider that helps clients build, support, and manage their IT infrastructures. We have operations in all 9 provinces across the country, over 200 clients and over 500 employees and as a Level 1 BBBEE we put to practice our commitment to South Africa’s transformation agenda, we are at the forefront...
-
Fire Detection Systems Engineer
2 months ago
Midrand, Gauteng, South Africa OTN Systems South-Africa Full timeJob DescriptionWe are seeking a highly skilled Fire Detection Systems Engineer to join our team at OTN Systems South-Africa. As a key member of our engineering team, you will be responsible for designing, supporting, and troubleshooting fire detection systems.Key Responsibilities Design and support fire detection systems in accordance with client...
-
Regulatory Affairs Specialist
1 month ago
Midrand, Gauteng, South Africa Emporium Full timeEmporium is seeking a skilled Regulatory Affairs Specialist to join our team in Midrand. This role offers a unique opportunity to leverage your expertise in pharmaceutical regulations and compliance.Job Overview:The successful candidate will be responsible for managing work streams, establishing regulatory priorities, and allocating resources. They will also...
-
Quality Assurance Specialist
3 weeks ago
Midrand, Gauteng, South Africa Autorecruit Full timeJob DescriptionWe are seeking a highly skilled Quality Assurance Specialist to join our team at Autorecruit.ResponsibilitiesInspect vehicles for defects in bodywork and paint, ensuring that all repairs meet safety and manufacturer standards.Measure and verify the proper alignment and dimensions of vehicles using specialized tools.Document findings and keep...
-
Quality Assurance Specialist
7 months ago
Midrand, South Africa MSD Full time**Responsibilities**: **1. Contribute to the maintenance of training programs for the COMET system.**: **2. Provide COMET training to site personnel.**: **3. Management of SAP site material master**: - ** Create, update and maintain PCR traces to link change controls with SAP.**: - ** Create and update Quality info record to allow Supply Chain to order...
-
ServiceNow Specialist for IAM Compliance
2 months ago
Midrand, Gauteng, South Africa OpenSource Intelligent Solutions Full timeJob Title: IAM Compliance and Risk Management ConsultantWe are seeking a highly skilled ServiceNow specialist to join our team at OpenSource Intelligent Solutions. The successful candidate will be responsible for implementing and managing ServiceNow's GRC module, with a focus on Risk Management, Policy Management, Audit Management, and Issue Management.Key...
-
System Integration Specialist
2 months ago
Midrand, South Africa IndSAfri Full timeCompany Description We are a financial services group in South Africa offering wholesale and retail banking services as well as insurance, asset management, and wealth management. Job Description We are seeking a highly skilled Integration Specialist to join our IT team within the banking sector. The Integration Specialist will play a crucial role in...
-
Payroll Specialist for Property Industry
3 weeks ago
Midrand, Gauteng, South Africa Quality Select Recruitment Full timeWe are seeking a highly skilled Payroll Specialist to join our client's team in Midrand. The successful candidate will be responsible for overseeing payroll procedures, ensuring compliance with laws and tax obligations, and maintaining accurate payroll records.Key responsibilities include:Processing payroll account transactions, including salaries,...
-
Quality Assurance Specialist
1 month ago
Midrand, Gauteng, South Africa Boardroom Appointments Full timeWe are seeking a highly skilled Quality Assurance Specialist to join our team at Boardroom Appointments.As a Quality Assurance Specialist, you will play a vital role in ensuring the quality and integrity of our services. This is an exciting opportunity to work with a dynamic team and contribute to our continued success.The salary for this position is...
-
Financial Systems Specialist
1 month ago
Midrand, Gauteng, South Africa Optimal Growth Technologies Full timeJob DescriptionCompany OverviewAt Optimal Growth Technologies, we are dedicated to delivering cutting-edge solutions that drive business growth. As a Financial Systems Specialist, you will play a crucial role in ensuring the smooth operation of our financial systems.Salary$85,000 per year, depending on experience.About the JobThis is an exciting opportunity...
-
Fire Detection Systems Specialist
2 months ago
Midrand, Gauteng, South Africa OTN Systems South-Africa Full timeFire Detection Engineer/Technician Job SummaryThe Fire Detection Engineer/Technician will be responsible for providing technical support and expertise in the design, installation, and maintenance of fire detection systems.Key Responsibilities:Design and support fire detection systems in accordance with client specifications and regulatory...