2X QC Reviewer at Biovac

Cape Town, Western Cape, South Africa -

Full Time

Start Date

Immediate

Expiry Date

25 Jun, 26

Salary

0.0

Posted On

27 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Integrity, GMP Compliance, cGMP Adherence, Analytical Chemistry, Microbiology, Biochemistry, Laboratory Audits, OOS Investigations, SOP Creation, Pharmacopeial Requirements, Regulatory Guidelines, Data Review, Analytical Methodology

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 2X QC Reviewer to join a goal-oriented team. QUALIFICATIONS NEEDED: National Diploma in Analytical Chemistry, Microbiology, Biochemistry or related field NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE: At least 2 to 4 years' experience within the pharmaceutical/ biotech manufacturing/ quality control or similar position. Laboratory and analytical methodology experience Good understanding of Data Integrity principles (FDA 21 CFR Part 11 compliance, ALCOA++) KEY DUTIES & RESPONSIBILITIES OF THE ROLE: Core Technical Delivery: Thorough review of all laboratory data generated against approved protocols, specifications, procedures and/or test methods. Monitor laboratory operations, perform internal audits, and ensure adherence to quality policies, procedures, and regulations (GMP, cGMP). Initiate OOS (Out-of-Specification) investigations and invalidated analysis observed during data review and completion of the initial investigation. Identify quality risks in analytical analysis and facilitate lab improvement activities. Documentation: Create, update, and maintain Standard Operating Procedures (SOPs) and quality system documentation. Provide guidance, training, and feedback to lab analysts on quality issues and best practices. Track RFT (Right First Time) within the laboratory. Checks of all laboratory logbooks for cGMP adherence. Perform duties as reasonably required, within your scope of practice. Excellent attention to detail to identify anomalies or non-adherence to procedural requirements Advanced understanding of pharmacopeial requirements and regulatory body guidelines for data integrity Application Deadline: 19 April 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 thoroughly reviewing all laboratory data against approved protocols, specifications, and procedures, while monitoring lab operations to ensure adherence to quality policies and regulations like GMP and cGMP. Key duties also include initiating Out-of-Specification investigations, identifying quality risks, and managing documentation such as SOPs and logbooks.