Specifications 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

Quality Management, Analytical Chemistry, Biochemistry, Microbiology, Laboratory Analysis, Pharmacopoeia Requirements, Regulatory Guidelines, Site Dossiers, Change Controls, Analytical Methods, Data Storage, Reporting, Database Management, Process Optimization, SOP Adherence

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 Specifications Evaluator to join a goal-oriented team. QUALIFICATIONS NEEDED: BSc in Quality Management or National Diploma in Analytical Chemistry/Biochemistry/Microbiology with 2 to 4 years related experience. NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE: Laboratory and analytical methodology experience. Understanding of various pharmacopoeia requirements and regulatory guidelines. Understanding of site dossiers. KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Core Technical Delivery: Compile new, or update existing raw material and finished product specifications and method of analysis documents using appropriate data and template Circulate documents for review and approval, and issue final document for use within intended deadlines Perform routine specification updates based on evaluation and interpretation of current vs. latest Pharmacopoeia requirements, supplier specifications and methods of analysis, dossiers, and DMFs Initiate and manage change controls to update specifications and MOA documentation based on adequate supporting information Evaluate and review impact of requests for changes, and submit changes for approval Handle queries related to specifications and MOA for raw materials and finished products Evaluate analytical methods for new specifications/products Verify that the QC laboratory can perform an analytical method reliably and precisely for its intended use Document and store data according to SOPs and regulation 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 core technical delivery involves compiling or updating raw material and finished product specifications and methods of analysis documents, ensuring circulation for review and approval within deadlines. Responsibilities also include initiating and managing change controls, evaluating change impacts, and handling queries related to specifications for raw materials and finished products.