Product Owner - Cape Town at Haleon

About the role

• To effectively and independently own and lead all elements of the Product Lifecycle for specific products or product family and to ensure that the product is delivered to the highest levels of quality and robustness.

Key responsibilities

• Performs Technical Risk Assessments (TRA) and Process Validation/ Process Performance Qualification (PV/ PPQ) on products assigned to ensure that the necessary process robustness is built into product manufactured and packed on site.
• Performing Continued Process Verification (data trending) on critical quality attributes, critical process parameters and critical material attributes to identify process risks and/or improvement opportunities. Prepares the Annual Continued Process Verification Report to support the Periodic Product Review process.
• Execute Performance Qualification (PQ) of new systems or when changes are made to existing systems.
• Provides technical input into any changes/ influences on the manufacturing, packing, cleaning and analytical processes, as well as pack design and associated specifications (raw material and finished product).
• Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D.
• Provides technical input to regulatory submissions for first file, post-approval submissions, periodic product reviews, internal and external audits.
• Maintains current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs).
• Troubleshoots problems that occur and provide input into root cause analyses to support the investigation and resolution of OOTs, product complaints and deviations, in conjunction with QA, Engineering and Operations.
• Ensuring all Cleaning processes are validated and maintained. Provides technical expertise with respect to cleaning processes and systems in support of Product Life Cycle Management/ Process Robustness and other GSK, EHS risk assessments for new and existing processes or site initiatives.
• Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards.
• Conducts management monitoring (self-inspections) and supports and provides technical input to internal, Compliance Assessment Group, third party and regulatory audits.

Qualifications and skills

Required

• National Diploma/Bachelors in scientific field
• Minimum 3 years of work exp in similar role.
• Demonstrated experience in the Pharmaceutical or FMCG industry.
• Experience in performing the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, Quality by Design, Validation and Change Control.

Preferred

• Bachelor’s Degree.

Other Skills/Qualifications

• Good communication and documentation skills.
• Good organizational skills and attention to detail.
• Good analytical skills.
• Team player.