Reference: DBN003527-SS-1
A leading pharmaceutical company has a 6 month contract position for a QA Assistant.
Duties & Responsibilities
Key Responsibilities:
- Drafting of procedures in the company's RSA format
- Tracking, documenting Procedure (SOP) Change control
- Circulating reviews, collecting information or comments. Update procedure accordingly and circulate.
- Tracking signatories to due dates
- Arrange training sessions, documenting training/registers and archive.
- Effective date review and implementation. Communication and archive. Version control with further updates and documenting redundant process.
- Maintain the SOP/Files master file.
- Assisting with external site information collection and follow-up. Not just pertaining to MD but also medicines to free up some time form current QA Manager to participate in procedure co-review.
- Routine information collection, documenting, circulating for review and closure. Maintaining of registers, trend analysis, escalations, extensions and closures.
- Drafting of Clause by Clause internal audit and review. Assisting with internal audit information collection.
- Coordinating information for QMS review. Arrange review meetings, taking minutes, list actions, follow-up and ensure review for closure.
- Assisting with updating of current medicine QMS to be in line with new parallel MD QMS. This will be on top of current routine review process. Drafting of documents, tracking reviews, incorporate comments, tracking signatories, collecting training information, document implementation (effective date).
- Drafting and maintaining of policy / regulation register impacting site.
- Collecting information from different departments within MD division. With QMS in effect. Risk assessments, planning and executions. To ensure separate archive and documentation for MD reviews / audits.
- Coordinate with different departments (HR, Logistics, Regulatory, Marketing, Sales, Medical, QA) ensuring correct QMS execution for data collection with ISO certification
- Assist with ISO correspondence, observations, CAPA, tracking and closure.
- Coordinate pro-active customer feedback process.
- Ensuring external product training records are maintained.
- Medical Device File – Assisting with the filing of the information and ensure correspondence with file information and PRS, release forms and actual product information.
- Maintain and update Audit readiness Tracker during review meetings and with identified issues.
- Quality manual: Keep updated and ensure with new product information relevant clauses applicable are identified and updated accordingly.
- Updating of CRMs with IHS.
Requirements and Skills:
- Post Basic Qualification
- Experience as a QA Assistant in the Pharmaceutical industry
- Ability to work independently as well as collaboratively in a fast-paced, high energy organization
- Excellent verbal and interpersonal skills.
- Computer literacy.
- General knowledge of the registration guidelines.
- Understanding the regulatory environment in South Africa.
Behavioural Skills:
- Attention to detail.
- High level of integrity and adherence to all compliance guidelines.
- Willingness to take initiative related to administrative issues.
- Willingness to up skill in the requirements for the compilation of medicines registration dossiers.
- Customer-focused and performance-driven.
- Egalitarian and trusting.
- Flexible and adaptive.
- Performance driven.
- Ability to work independently as well as collaboratively, multi-task and work under pressure.
- Planning and organizational skills.
- Professional interpersonal skills.
- Team player.
Candidates that meet the criteria may submit their applications via this portal or via vacancy link on
Should you receive no feedback within 7 days, please accept your application as unsuccessful.
#J-18808-Ljbffr
