Quality Assurance Manager

Kenvue is currently recruiting for:

Quality Assurance Manager

This position reports directly to the Site Quality and Compliance Lead and is based in Cape Town, South Africa.

Who we are

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSONS® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.

Broad Summary:

• Ensures that products released to the marketplace are manufactured and processed in accordance with company policies, procedures, regulatory requirements and product specifications.

• Ensures adequate communication of all quality impacting activities to all levels of the business.

• Inter-departmental interaction to ensure all projects comply to quality standards.

• Management and coordination of subordinate activities and ensure that execution is in accordance with all company guidelines.

• Responsible for overall GMP and GDP compliance situation of plant processes, facilities and equipment

Assurance:

• Ensures that all Master documentation comply with Regulatory and company QA standards.

• Ensures that products are Lot Released in accordance with the manufacturing and packaging procedures,

• regulatory requirements and product specifications. This responsibility is delegated on a day-to-day basis from the

• RP who is ultimately responsible for this function. Therefore, there is a pharmaceutical reporting line from the RP.

• Authorizes disposition of all products.

• Oversees the management of consumer complaints and adverse event reporting.

• Management of deviations, product hold and recall processes.

• Liaison with holders of certificate of registration (HCR) where necessary.

• Oversight of the companys stability program and review of Annual Product Reviews.

• Management of validation program to ensure compliance with local regulatory and corporate requirements

Quality Systems:

• Coordinate, develops and maintains Quality Assurance systems and procedures to ensure compliance with all

• regulatory and corporate requirements in manufacturing, packaging and testing of all J&J products.

• Trending of statistical data for compilation and presentation of various management reports, such as the Monthly

• Dashboard and quarterly Management Quality Review (MQR).

• Participates in assessing the facility using audit processes ensuring the level of conformance to current Good

• Manufacturing Practices (cGMP) requirements.

Additional Responsibilities:

• Proposes and implements improvements and corrective actions based on monitoring, tracking and trending of product performance, deviations and change.

• Assists with internal auditing program for complying to cGMP and applicable J&J requirements.

• Assists in the Management of the Annual Product Reviews (APR) program in accordance with company requirements.

• Ensures that all documentation services are completed timeously

• Manages and investigates Customer Complaints and reports the Adverse Events (AEs)

• Assists in the Management of the Stability Program to ensure that all regulatory and company requirements are met.

• Laboratory Review meetings to review analytical- and microbiological investigations prior to close out where required.

• Oversight of the Validation Programme to ensure compliance with local regulatory and corporate requirements

• Human Resource Management

• Assists in the compilation and presentation of quarterly Management Quality Review (MQR)

• Participate in Problem-Solving and Quality Improvement initiatives associated with across all departments

• Interacts with cross-functional teams to ensure that investigations consistently meet quality standards.

• Active support in resolving product quality issues

What We Are Looking For

Required Qualifications

• Experience 5+years in a similar role within an FMCG/ Consumer environment

• Bachelors degree in B. Pharm/Diploma in Pharmacy or related.

• Knowledge and experience of Quality Assurance Systems with a general understanding and application of cGMP Principles (Act 101 1965)

• Experience in Quality audits

• Experience in multi-departmental projects/ investigations

• Experience in Pharmaceutical environment highly recommended

Essential Skills:

• Good knowledge and understanding of the SA GMP guide.

• Maintain high work ethic and business standard

• Good planning and administrative competencies - Ability to deal with a diverse task.

• Good verbal and written communication skills.

• Logical approach to problem solving and trouble shooting.

• Good team player with the ability to convene and steer meetings.

• A self-motivator with high energy levels to meet tight deadlines

Whats in it for you

• Competitive Benefit Package*

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

• Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment 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.