Job Description

Technical Product Owner Opportunity Here in Cape Town Northern Suburbs

Requirement:
Bachelors Degree in Scientific, Technical or Engineering

Reason:
Role requires knowledge of the pharmaceutical processing principles which requires a tertiary degree in scientific, technical or engineering.

Job Purpose
To own and provide technical leadership for products at a site level and to ensure that the product is delivered to the highest levels of quality and robustness.

Responsibilities include effectively and independently own and lead all elements of the Product Lifecycle for specific products or product family.

Key Responsibilities

• Performs Technical Risk Assessments (TRA) and Process Validation (PV) on products assigned to ensure that the necessary process robustness is built into product manufactured and packed on site.
• Performs Continued Process Verification (data trending) on assigned products to proactively identify opportunities for process improvement.
• Performs Performance Qualification (PQ) on systems as assigned in alignment with QMS policies.
• Ensures Quality by Design (QbD) principles are applied, and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialization of new products from R&D, and subsequent transfers to other sites.
• Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the 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
• Assesses the product quality impact of any change that can impact CQAs/CPPs via review and update of TRA and PCS
• Provides technical input to regulatory submissions for first file, post-approval submissions, periodic product reviews, internal and external audits.
• Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA, Engineering and Operations
• 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)

Only short-listed Candidates will be contacted.

Manpower