Coordinator validation & CSV
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Posted Date: Sep 4 2023
In compliance with the Labor Code, the Public Health Code, Regulations, Good Manufacturing Practices, GSK Quality and EHS Standards and internal procedures:
- Ensure compliance with regulatory, QMS, EHS and GMP requirements in validation activities.
- Coordinate validation activities (Validation Life Cycle, Validation of cleaning) for the Boudouaou VS AB and NAB site
- Update the performance indicators related to its field of activity.
- Continuous improvement of its sector of activity.
- Contribution to the work of the team and the achievement of collective objectives.
- Perform the tasks assigned to him by his Manager.
1-Drafting / Participation in the development of the Master Plan for the validation of the Site 'SVMP'.
2-Ensure compliance with internal and external policies and regulations of manufacturing processes, including laboratories, cleaning, premises, utilities, equipment, computerized systems and processes impacting product quality:
- Ensure that the site is fundamentally aware of and proactively implements current validation practices, with a particular focus on the impact on patient safety, product quality and record integrity.
- Ensure that gap analysis has been performed against general validation policies, that issues have been resolved, and corrective and preventive actions have been put in place.
- Ensure that the site complies with the company's validation policies and applicable legislative requirements by defining and maintaining standards for validating manufacturing processes, including laboratories, cleaning, premises, utilities, equipment, computerized systems and processes impacting product quality (e.g. GMS QMS, CAP) via operational validation procedures.
- Drafting and updating of department procedures in accordance with GSK internal policies and standards (QMS) and applicable regulations.
- Liaise with validation experts across the GSK network to share best practices in methods and tools.
- Provide accurate updates with respect for scheduled validation activities and reporting progress.
- Ensure that all centrally established tools, templates and materials are available and relevant to the site.
- Deliver and provide training/mentoring for the Validation Life Cycle, Cleaning Validation and CSV process to all relevant site personnel.
- Ensure that key personnel, training and expertise are in place before commencing any validation activity.
- Draft, review and approval of validation plans, validation protocols and associated validation reports in accordance with QMS requirements, regulations associated with the contracts provided and, where applicable, local regulatory requirements.
- Approve validation documentation as defined in validation plans.
- Provide GxP and regulatory inputs to computerized systems implementation projects with a particular focus on the impact on patient safety, product quality and record integrity.
- Coordination and proactive planning of validation activities with all relevant departments.
- Evaluate the technical difficulties that may be encountered in order to anticipate them and minimize the financial risks associated with a validation.
- Stand-alone resolution of issues encountered.
- Perform periodic validation reviews by ensuring that premises/computerized systems/processes/manufacturing processes/equipment/products retain their validated status.
- Carry out L1 audits in its field of activity with follow-up of the actions resulting from them.
- Participate in the preparation of internal audits (L2, L3) and inspections of regulatory authorities (L4).
- Provide inspectors/auditors with answers related to Life Cycle Validation and Cleaning Validation.
- Develop and maintain links with the region and regional validation teams for learning and contributing to GSK validation practices.
- Proactive management and monitoring of validation deviations.
- Proactive management and monitoring of CAPAs assigned to it.
- Bac + 5 , Higher Science Diploma(Engineering, Biology, Chemistry, Process Engineering or Pharmacy)
- 1 year in the pharmaceutical field.
- Knowledge of manufacturing processes, computerized systems and/or engineering.
- In-depth knowledge of theValidation Life Cycle of products and site systems (e.g. manufacturing processes, computer systems, control systems, analytical equipment, Excel files, etc.).
- In-depth knowledge of local regulatory body GxP standards for the area of expertise.
- Be up to date with GSK internal policies, standards and best practices (e.g. validation, IT, Engineering, analytical equipment).
- Excellent organizational skills and ability to manage several critical priorities. Strongly results-oriented; ability to deliver and overcome obstacles.
- Excellent customer-focused interpersonal and interpersonal skills and exceptional customer service.
- Strong written and verbal communication skills.
- Strong leadership skills and demonstrated ability to function in an independent and team environment.
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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