Quality Engineer
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Quality
The Quality Engineer is responsible for providing quality oversight for the introduction of new products and production equipment to ensure SOP/GMP compliance at the Cleveland Manufacturing Facility. Works closely with MS&T, Validation, Engineering and Operations to provide compliant solutions for commissioning, qualification, and validation activities. Works with Production personnel to complete on-the-floor, in process batch record review, resolve all batch related issues or escalate to the Quality Assurance Manager as appropriate, and ensure good documentation practices are being followed. Recommends corrective actions or process improvements that will eliminate the potential for manufacturing deviations.
Key Responsibilities
- The primary focus of the Quality Engineer covers: Technical Transfers of New Products; Validation and Commissioning/Qualification of Facilities, Equipment and Processes; On Floor oversight in Manufacturing and Packaging areas; Incoming Material Inspection/approval; Review and disposition of batch records and packaging records.
- Initiate or execute Action Plan requirements as needed to address investigation or compliance related activities.
- In coordination with Engineering personnel, Evaluates the manufacturing areas, equipment and processes for recommended improvements that will eliminate the potential for deviations.
- Identify deviations and ensure the deviations are initiated according to procedures
- Work closely with Production personnel to complete in-process batch record review, resolve batch related issues, and complete timely final batch record approvals in order to meet release scheduling.
- May be required to be on the floor and present to provide quality oversight for all critical manufacturing processes. Ability to make independent decision regarding quality related concerns or issues.
- Demonstrates a proficient knowledge of the manufacturing process and site procedures.
- Addresses daily quality concerns and questions related to operating and environmental issues. Implements and follows up on corrective actions.
- Clearly communicates complex issues to Management personnel.
- Manage metrics on a regular basis, as applicable.
- Completion of gowning qualification and maintaining status for entry into Controlled Classified Areas. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
- Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs.
- May be required to perform AQL checks on product when necessary and maintain AQL qualification status.
- Provide, as needed, real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
- Participation in gathering of data needed for the Annual Product Reviews.
- Perform additional tasks in relation to quality issues as agreed with the Director, Quality Assurance.
- Manage and escalate Quality issues to the Quality Assurance Director, as needed.
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Is cross-trained in MQA functions and may provide backup support to MQA Supervisors.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
Qualifications
- B.S. in Life or Physical Science preferred with two (2) to five (5) years relevant professional experience or five (5) plus years of relevant professional experience
- Experience authoring/approving SOPs. Proven ability to write clear, concise instructions
- Knowledge of a CGMP production facility and/or inspection processes required
- Validation experience supporting Sterile Manufacturing Production Equipment (non-laboratory) and Processes is highly desired. i.e. - Autoclave, Clean Steam, Water for Injection, Compounding, HEPA Carts, Vial Washer, Lyophilizer, etc.
- Ability to critically evaluate and troubleshoot complex problems and articulate clearly to management is essential
- Well-organized and detailed oriented professional, with strong verbal and written communication skills
- Quality or Pharmaceutical certifications is a plus
- Sterile Manufacturing and/or Lyophilized product experience with a commercial production site is strongly preferred
Physical Requirements of the Role
Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. Work regularly under desirable conditions of the office setting but has occasional exposure to moderately disagreeable features of noise, heat or production conditions.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Produktspecialist
- København
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