Professional Master Administrator

Job description

Sanofi Pasteur: The world's leading vaccine company

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines.

Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases

Mission

The purpose of the Professional Master Administrator is to manage the contamination control program, and to support the maintenance and continuous improvement of sterility assurance practices on-site. This position requires on-going collaboration with production personnel, various technical and quality professionals within Sanofi Pasteur to ensure that all monitoring regimes and sterility assurance practices are in compliance with company standards and regulatory requirements.

Key accountabilities

1. Management of the MASTER system, support and report generation. Manage the security access levels; perform administration and routine maintenance activities on a daily basis in the MASTER system. (35%)

This includes:

·  Initiating and maintaining user profiles.
·  Provide regular updates and notification of EMFs requiring action to actioned users and management.
·  Routine updating/modification of master data information within the MASTER system without review by manager.
·  Provide support and consultation to general users for the MASTER system.
·  Maintain file documentation for all archived and newly created templates.
·  Maintain file documentation for any changes/edits required to EMFs.
·  Providing support and assistance in changes made by internal and /or external consultants to the system followed by validation of these changes. This will also require backups and liaison with IS, as required, to overcome any technical issues that may be encountered. Write URS for any upgrades to the MASTER system.
·  Review and approve protocols and reports in support of any validation activities.
·  Review and approve change request forms submitted by users for EMFs requiring corrections and update EMFs.
·  Testing of any new version releases prior to rollout.
·  Provide training to end-users on the MASTER system, including:
·  Creating documented training to convey the MASTER functionality to users.
·  Schedule and provide training for new users and provide refresher/update sessions as changes are made to the system.
·  Deliver information in a clear, interesting and easily understood manner that will facilitate learning on the MASTER system.
·  Keeping a current list of active and adequately trained users of each category.

2. Routinely create and provide reports from MASTER for trending and investigation of non-conformances. (5%)

·  • Create ad-hoc reports and create/improve routine reports to meet the needs of management and personnel in QOSA.
·  Provide departments with environmental and utility systems monitoring information as required or when requested.
·  Create ad-hoc updates and reports on personnel, environmental and utility systems monitoring for response to regulatory agencies.

3. Liaise with manufacturing/testing to negotiate target dates for use of old EMFs and implementation of new templates. (10%)

·  • Negotiate end date for templates that are no longer valid due to error(s) or require updates, e.g. changes to alert and/or action limits, header information.
·  Negotiate start date for new templates that are replacing existing templates.
·  Updating of environmental and utility systems monitoring SOP(s) due to changes in alert and/or action limits, addition/deletion of sampling location(s), etc.
·  Routinely check the status of EMFs in the system and informing manufacturing/testing on which EMFs have been created and have not been used.

4. Maintain all documentation relating to the operation of MASTER. MASTER is an electronic system used for compliance. All electronic systems must be validated and include supporting documentation to prove that the systems have been validated. Furthermore all changes to MASTER must be evaluated and possibly revalidated and documented. All operations that are related to MASTER must be documented and current such as data entry and maintenance.(10%)

5. Participate in working groups on trending and reports, and work on QOSA special projects (5%)

6. Management of PharmNet-Web System (35%)

Scope and dimensions

The current QOSA Training Program covers both Industrial Operations and Process Development facilities on site:

·  Approx. 100 operators required to be trained to enter 20 aseptic production platforms in 7 facilities
·  Completion of training requirements for aseptic/classified area operators must be adhered to in order to facilitate production demands and capacity planning.
·  Impact of incorrect assessment and/or conclusion on aseptic operator/processing training could impact risk and/or far reaching consequences on product quality and regulatory compliance.

Education and experience

Specific degree, duration of experience (Required to hold the job):

·  Minimum Honours B.Sc. (Microbiology, Chemistry, Computers or Related Science) plus a minimum of 12-24 months of previous relevant experience in a Quality Assurance or Quality Control environment in the pharmaceutical industry.

Competencies (LEAD model) – key competencies the job holder will be evaluated on (HOW in 9box):

Key technical competencies and soft skills:

·  Good knowledge of cGMP in pharmaceuticals/biological.
·  Good understanding of key related manufacturing activities including filling, formulations and sterile filtrations and related sampling and sample handling requirements.
·  A good understanding of environmental and utility systems monitoring.
·  Experience in validation, documentation practices and sample management.
·  Good problem solving skills and documentation skills.
·  Knowledge of SAP, Excel, Word, PowerPoint, Outlook and Access.

Hours of Work:

Monday to Friday: 8:00 – 4:00 p.m.

Sanofi in Canada embraces diversity in the workplace and is committed to achieving employment equity. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome applications from women, members of visible minorities, Aboriginal peoples and persons with disabilities.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

We are an equal opportunity employer

#GD-SP

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life