Stability Evaluator at Biovac

Cape Town, Western Cape, South Africa -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

0.0

Posted On

18 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Stability Trials Execution, Analytical Methodology, MCC Guidelines, ICH Guidelines, Pharmaceutical Standards, Compliance Requirements, Data Tracking, Database Management, Report Preparation, OOS Investigations, Chamber Management, Root Cause Analysis, GMP Adherence, SOP Review, Data Analysis, Process Optimization

Industry

Pharmaceutical Manufacturing

Description

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Stability Evaluator to join a goal-oriented team. QUALIFICATIONS NEEDED: BSc in Quality Management or National Diploma in Analytical Chemistry with 2 to 4 years related NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE: Laboratory and analytical methodology experience Prior experience in execution and control of stability trials Advanced knowledge of MCC and ICH stability testing guidelines Understanding of Pharmaceutical standards and compliance requirements Ability to interpret and implement policies, processes and objectives KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Core Technical Delivery: Handle, store and record scheduled stability samples according to SOP and standards. Issue the correct supply of scheduled stability samples to local and outsource laboratories for testing. Ensure the correct termination of stability trials for scheduled products that are no longer required for stability testing. Ensure accurate quantity of scheduled stability samples in stability chambers in accordance with legislated stock counts. Track and obtain stability data for all stability trials conducted at local and international laboratories. Record stability trials into stability database to track stability sample status and testing schedule. Prepare stability reports, evaluate results and identify trends. Assist with OOS stability investigations. Inspection and management of the stability chamber to ensure regulatory requirements are met. Conduct problem root cause analysis on chamber excursions/ failures and quality deviations. Report any equipment failure/breakdown and calibration failure and impact on the product quality being stored and monitor chamber performance. Monitor access to and maintain logbooks for access to stability systems/ chambers. Adhere to GMP quality systems and procedures. Review and update relevant SOPs to reflect current practices. Assist with SOP training in relation to stability monitoring activities. Document and store data according to SOPs and regulations. Consolidate information for reports on weekly/ monthly basis. Analyze consolidated data and provide recommendations. Compile detailed and standardized reports and consolidated documents. Monitor and control access to and set-up of electronic databases. Optimize and facilitate implementation of current processes in relation to core of position. Identify gaps in current policies and procedures. Propose changes or improvements to processes, tools and techniques. Perform duties as reasonably required, within your scope of practice. Application Deadline: 06 March 2026 If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful. We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity. Disclaimer: Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Responsibilities

The role involves managing scheduled stability samples, issuing them for testing at local and outsourced labs, and ensuring the correct termination of trials. Key duties include tracking stability data, recording trials in a database, preparing reports, evaluating results, and assisting with Out-of-Specification (OOS) investigations.