Posted Date: Aug 16 2023
Owns the process knowledge of the product(s) assigned throughout the commercial lifecycle, maintains the oversight on process capability, through data trending and statistical analysis of critical parameters, ensuring process(es) are robust, in continued state of validation and continuously improving. Ensures seamless flow of knowledge and information across functions, and with other Sites/MPU when applicable, with focus on the product(s) & associated process. Provides second line technical/scientific process support.
Your responsibilities:
Process/product oversight and knowledge:
Maintain the oversight of the process of the product(s) assigned ‘door to door’ at the Site/MPU (e.g. from raw materials to primary packaging).
Maintain the knowledge and the history of the product(s) process throughout the entire commercial lifecycle, since transfer from development to date.
Manage issues/risks detected through CPV, AQR/PQR, investigation, change control, data trending, etc and escalate to appropriate governance as needed
Single Point of Contact to Head of product steward:
Liaise with Head of product steward and with functions (Quality Assurance QA, Quality Control QC, Engineering, Regulatory Chemistry Manufacturing & Controls (Site conformance), etc), production management (e.g. Process UnitHead, Production Head, etc), shopfloor (e.g. Operators, Team Leaders, etc), with focus to ensure and improve product process capability, to keep up to date the knowledge of the process and to maintain the product/process in constant state of validation.
Create and maintain a product specific Technical Risk Assessement (TRAs)
Continued Process Verification (CPV), data trending and statistical analysis:
Track CPV parameters from production, QC, control systems, etc. Monitor all critical variables and key variables as appropriate for the assigned product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc) using statistical analysis and conducting regular product specific data trending.
Utilize data trending and statistical analysis to:
Deepen and broaden process understanding and knowledge.
Detect issues in process capability, such as systematic quality defects.
Identify trends of process deviations (e.g. deviation with common root cause).
Issue quarterly/annual data trending report.
Ensure data and trending is visible and communicated at shopfloor level.
Transfer OUT process:
Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed
Investigations/improvement on product:
Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams.
Actively participate and represent their product(s) & processes in the relevant committee, where the improvements on weak point products are planned, prioritised and monitored.
Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters.
Validation:
Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples.
Supports Validation Experts to assess need and plan validations / re-validations / verifications /AnnualMonitoring Batches, consulting approving and reviewing the process validation master plan, together with Validation Experts.
Write both Validation Protocols and Report
Testing Monograph ™ oversight:
Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content
Change control:
Participate and/or lead (case by case) the change controls to its products and related processes.
Ensure alignment of (regulatory) timelines for technical changes (e.g. DS), transfers or launch, major deviations.
Evaluate impact of change control on process validation
Annual Product Review/Product Quality Review (APR/PQR):
Review the PQR data and provide the correct level of discussion on it.
Training:
Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position.
Provide training to the shopfloor to elevate skills of operators and employees
Audit support:
Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
5 years experience
Lean/6-Sigma green belt certified or higher
Preferred Qualifications:
If you have the following characteristics it would be a plus:
Fluent in English and French (written and spoken)
Experience in process support, e.g. Process Expert role on the shopfloor of vaccines manufacturing and/or QA/QC.
Proven process understanding (Vaccines, GMP, Regulatory aspects).
Sound experience of data handling and applied statistics is a must.
Used to work in cross functional working teams
Good communication skill
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
#Li-GSK
If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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