QA Specialist

The role is a fixed term contract for 18 months.

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.

Position Overview - Basic Functions & Responsibility

Ensure compliance with Quality and regulatory standards and guidelines. Provide technical knowledge and remediate selected quality system gaps because of new or revised policies, procedures and guidelines and ensure that practices in the relevant systems are in alignment with our Manufacturing Division's SOP’s and guidelines.
The ability to adapt current work processes to meet emerging needs and changes in job responsibilities. Lead, facilitate and participate on cross-functional teams to collaboratively address issues and achieve project milestones.
The ability to coordinate work tasks with others for timely completion and to avoid potential setbacks. The ability to adjust work to accommodate sudden task changes and avoid potential threats to meeting task deadlines.
The ability to proactively share information through appropriate mediums to keep others informed.
The ability to evaluate data and information to determine accuracy and find potential errors. The ability to independently solve problems that arise within job responsibilities and expectations
Prepares documents for review prior to QA release. Review of batch documentation prior to release.
Helps with compilation of Annual Product reviews
System Owner for Deviation management.
Responsible for Metrics for Quality Council preparation and Site Quality Metrics reporting.
Release of packaging components.
Maintenance of Supplier Transparency database.
Management of External contract laboratories

Primary Activities

Assist with compilation and submission of Annual Product Reviews as per site schedule
Acts as system owner for Deviation management. Responsible for site compliance to procedures, deviation trending reports and site training.
Attendance of Community of practice meetings for Deviation management.
Responsible for maintenance of Supplier Transparency data base for site, Supplier Transparency Periodic reviews and site metrics review as per Spotfire tool. Site representative at Community of Practice meeting.
Performs batch record review for products packaged in Midrand according to batch record review procedures. Ensures all queries are resolved by liaising with IPT. Performs control print reconciliation and filing of retention samples. Runs change control and Orion reports.
Control print of Release Checklists for Bulk and Finished Goods.
Responsible for monthly removal and destruction of expired retention samples.
Responsible for management and release of Packaging components:
Change control, specifications, purchase specifications for primary packaging components, etc.
Management of External Contract laboratories (NCL, NWU, CCL, KLS); sending of samples and documentation, ensure timeous receival of test / release results, management of laboratory deviations, method transfers, etc.
Logging of internal complaints via Deviation management System of the Issue Management System.
Participates in activities of the Quality Council. Preparation of metric reports as required. Maintenance of the QUADS database.
Seek opportunities for continuous improvement in Quality activities and projects and identify quality related trends.
**Pharmacovigilance**: Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that they become aware of to the Designated Point of Contact (DPOC)

Qualifications/ skills

Minimum tertiary degree in Pharmacy or equivalent qualification
Knowledge of pharmaceutical Good Manufacturing Practices and global regulatory requirements
Problem solving skills. Able to deal with situations requiring interpretative and evaluative thinking. Able to make unbiased and honest judgements.
Proficiency in use of Microsoft Word, Excel software
Teamwork skills and flexibility
Takes initiative
Good oral and written communication essential

Experience required

At least three years experience in the pharmaceutical QA environment
Good understanding of GMP particularly with reference to packaging operations.

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 d