C&Q Technician

Kenvue; Cape Town; On-site; ZAR 50 000 - 200 000; Full time

Job summary

A leading pharmaceutical company in Cape Town is seeking a C&Q Technician to develop and execute validation plans and manage compliance activities. The role demands a relevant degree, 3-5 years of experience, and proficiency in quality management systems. Interested candidates will work closely with regulatory agencies and internal teams to ensure all processes meet standards.

Benefits

Competitive Benefit Package

Learning & Development Opportunities

Employee Impact Networks

Qualifications

• Relevant degree or equivalent in Life Science/Chemistry/Math.
• Experience in qualification/validation in the pharmaceutical industry.
• Knowledge of cGMP, cGEP, cGDP regulations.

Responsibilities

• Develop User Requirement Specifications and Validation Risk Assessments.
• Perform Commissioning and liaise with other departments.
• Manage and maintain the company validation plan.

Skills

Problem-solving skills

Organizational skills

Documentation experience

Education

Relevant Degree in Life Science/Chemistry/Math

3-5 years’ experience of qualification/validation in a Pharmaceutical company

Tools

Proficiency in Microsoft Office (Word, PowerPoint, Excel)

Job description

Overview

Kenvue is currently recruiting for a: C&Q Technician

Role reports to: SA Engineering Campus Leader

Location: Europe/Middle East/Africa, South Africa, Gauteng, Johannesburg

Work Location: Fully Onsite

Travel %: Minimal

Pay: 24

What You Will Do

This position reports into Engineering & Reliability Leader and is based in Cape Town, South Africa.

The Commissiong & Qualification technician is responsible for generating and maintaining the validation plan in line with GMP and successfully carry out on all Facilities, Utilities (HVAC, Water, Compressed Air and other), Equipment, Systems.

Key Responsibilities

• Development of User Requirement Specifications
• Development and execution of System Impact Assessments and Component Impact Assessments
• Development and execution of Validation Risk Assessments and Design Reviews
• Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
• Perform Commissioning (includes Factory Acceptance Testing and Site Acceptance Testing) as required and liaise with other departments
• Validation of Automated Systems
• Perform periodic reviews for Equipment, Facilities, Utilities, Systems
• Re-qualification of Equipment, Facilities, Utilities, Systems
• Interact with all areas and levels of the company in addition to regulatory agencies, vendors, consultants, contractors and other intended parties
• Follow and review site validation/qualification SOPs to ensure they are in line with current compliance requirements from corporate and regulatory authorities
• Participate in corporate, regulatory and internal audits
• Maintain up to date knowledge of corporate and regulatory standards
• Manage and maintain company validation plan and ensure validation/ qualification activities are successfully carried out
• Maintain the Validation Master Plan schedule and Validation System

Required Qualifications

• Relevant Degree in Life Science/Chemistry/Math (Not necessarily from Biology/Microbiology) or equivalent
• 3-5 years’ experience of qualification/validation in a Pharmaceutical company
• Experience with cGMP, cGEP, cGDP
• Strong problem-solving skills and documentation experience preferred
• Strong organizational and time management skills.
• Qualifications background.

Desired Qualifications

• Very strong Quality Analytics knowledge and understanding (ISO / FMEA / HAZOP etc.)
• Demonstrated knowledge of working within a quality management system and cGMP and regulations 21 CFR 211, EU Annex 11 and 21 CFR Part 11
• Must have knowledge of Deviations, Investigations, Change Control, CAPA and Risk Assessments within the Pharmaceutical Industry quality system
• Must have basic Protocol and execution and Report writing skills
• Ability to work independently and as part of a team
• Proficiency in relevant software and tools
• Proficiency in Microsoft Office, including Word, PowerPoint, and Excel.

What’s In It For You

• Competitive Benefit Package
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.