C&Q Technician

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在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

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我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

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你會做什麼

C & Q technician

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

What we do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who we are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here.

Role reports to: SA Engineering Campus Lead

Location: Cape Town, South Africa

Travel %: Minimal

Pay: 24

What you will do

What you will do

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 SOP’s 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

What we are looking for

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.

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