Liquid & Soft Gel Product Owner
GSK -
Cairo, EgyptPosted 5 years ago45People have clicked1 open position
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Job Description
Job Purpose
To own and provide technical leadership for the products in the liquid and Soft Gel VS on site and to ensure that the products are delivered to the highest levels of quality and robustness.
Support and/or lead the technical aspects of a product during product transfer, product trouble shooting and change assessment, in accordance to regulatory requirements and GSK standards ensuring that the product is delivered on time to the highest levels of quality and robustness. Support in implementing technical elements of the product lifecycle on site.
Key Accountabilities/Responsibilities:
- Recognised as the principal point of contact for all aspects of knowledge on the products, performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site as appropriate.
- Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the products: Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions, Continued Process Verification and Process Robustness Assessment. 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.
- Ensures robust and well understood process and product control strategy are transferred during technical transfer till commercialisation.
- Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, and associated specifications including technical input to the lifecycle validation approach for the product.
- Responsible for assessing the product quality impact of any change (AL1/2) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2 primary changes impacting API material properties, assessment of impact of API/excipient changes on the dose form, via the Material Risk Assessment process (MRA), Packaging Risk Assessment with the support of above site experts.
- Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the products for which he/she is accountable, and above site with other Product Owners.
- Provides technical input to regulatory submissions for technical projects including new SKUs and products under composition change, annual reports, Periodic Product Reviews, and 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 and operations.
- Identifies, develops and trains successors for the role, if needed, and coaches others in his/her area of expertise, ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.
- Ensure that EHS, QMS and GPS are supported
Job Requirements
Basic qualifications:
- Bachelor degree of Pharmacy.
- 3-5 years of experience in Production manufacturing and/or operational Quality and/or Process Validation experience in Pharmaceuticals and/or FMCG, preferably in multinational organization.
- Demonstrated experience in the Pharmaceutical or FMCG industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, validation and change control.
- Has detailed knowledge of at least single dosage form including unit operation understanding, packaging processes, plant equipment and analytical testing with general knowledge in other dosage forms.
- Capability to develop the competency as TRA facilitator Level 1, (‘Proficient’ level as defined by the TRA competency framework) and MRA accredited Level 1.
- Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs.
- Experienced in improving products, processes and troubleshooting execution of technical activities including trials and validation activities.
- Experienced in product transfer, with an understanding of the product development phase.
- Proven track record of expertise in delivery/participating in technical risk assessments.
- Has a thorough knowledge of GMP requirements, SOPs, regulatory guidelines and policies and EHS requirements.
- Able to assess/interpret statistical data e.g. process capability, control charts, DoE, MSA
- Demonstrates ability to contribute effectively to influence matrix teams and colleagues in other functions.
- Demonstrated ability to mentor operational staff and support functions
- Flexibility in work schedule.
- Excellent interpersonal skills.
- Excellent command of English language.
- Excellent team working skills with the ability to communicate at all levels.
