Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Post : Validation Scientist
Job Description
POSITION SUMMARY
The Validation Scientist is responsible for managing assigned qualifications, re-qualifications and other duties assigned. The position works closely with all departments in the facility to coordinate related qualifications. Responsible for the preparation, execution and completion of validation protocols, which include: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as Re-qualification (RQ) of facility equipment and utility systems. Protocols involve the validation of all critical manufacturing systems, equipment and processes. Responsibility encompasses completion of validation activities that meet the requirements of the cGMP's as well as the pharmaceutical industry standards and comply with site validation policy.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
• Coordinate and maintain critical validation responsibilities, such as scheduling, projects, etc.
• Prepare protocols including, Cycle Development Protocols, Investigational/Engineering Study
• Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification
• (PQ), Amendments and Supplements for critical systems as directed by Validation Supervision.
• Reviews protocol drafts and resolves circumstances in order to achieve management preapproval.
Researches equipment/processes, and establishes parameters and methods to test equipment to meet validation requirements.
• Coordinates the execution of qualifications and all aspects of the validation project with other departments, including but not limited to: Operations, Quality Control, and Quality Assurance for completion of validation requirements. Also, participates in the execution of protocols and maintains documentation as evidence in compliance with current good documentation practices.
• Review, analyzes and compiles protocol data in preparation of interim and final reports for management review and approval.
• Executes Re-qualification (RQ) studies and periodic reviews, to assure equipment is maintained within its qualified condition.
• Maintains equipment used for qualification purposes.
• Supports and participates in change control process for critical system/equipment updates and repairs performed through the Work Order control mechanisms. Fully understands the requirements of each change control procedure.
• Troubleshoots and resolves issues with equipment as it impacts the validated condition.
• Supports the removal of product holds due to qualification studies in a timely manner.
• Creates and revises SOPs in support of departmental operations.
• Works on multiple projects with short notice, including any shift to complete project and weekends if necessary.
• Must be available to work overtime when necessary.
• Performs other duties as assigned and required.
Candidate Profile
• Bachelor’s degree in a Scientific, Engineering or related field or equivalent work experience.
• Good technical writing skills and verbal communication skills are required, with knowledge of various computer programs.
• Must be able to learn and develop a working knowledge of cGMP's as needed.
• Experience in the above listed job responsibilities is a plus.
• Must be able to focus on computer terminals for an extended period of time.
• Ability to clearly read and write English.
• Ability to work effectively under pressure to meet established deadlines.
• Ability to stand, sit for long period of time, walk, drive and lift 0-25 lbs.
• Specific vision requirements include reading both computer and written documentation. Frequent computer use is required along with the ability to clearly see and focus on objects and color at close and far distances with good depth perception.
• Must be able to wear a respirator for a period of time and meet personnel growth requirements for the Aseptic Area.
Additional Information:
Job ID: 1541
Qualification : Bachelor’s degree
Location : USA
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 30th March, 2018
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