Compliance Quality Assurance Specialist
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Quality
Would you like to join an award winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Our Bedford facility is seeking a Compliance Quality Assurance (CQA) Specialist. The CQA is responsible for providing quality oversight to Doc Control, Change Control, Deviation Management, APR’s, Auditing, Laboratory, Complaints, Reprocess, Recalls and Supplier and Material Management to ensure product quality and SOP/GMP compliance at the Cleveland Manufacturing Facility.
Key Responsibilities
- Ensure processes and products are in compliance with all local, state, and federal regulations.
- Author, Review, and Approve SOPs and qualification/validation documents.
- Support management of the deviation and CAPA system including review / approval of incidents and deviations, assurance of on-time completion, verification of effectiveness of CAPAs, and reporting of metrics.
- Support management of the change control system including review of proposed changes, approval of completed changes, assurance of on-time completion, and reporting of metrics.
- Perform self-assessment inspections of quality system, facility and equipment, materials, production, packaging and labeling, and laboratory for compliance to regulations and site procedures.
- Support customer audits and health authority inspections.
- Management of the supplier and material program including supplier and material qualification, processing supplier change notifications, issuing supplier complaints, and assessing supplier performance.
- Generate data and reports for monthly and quarterly quality management review.
- Support management of the stability program for marketed products including review of protocols, data, reports, laboratory investigations, and deviations.
- Generate data and prepare Annual Product Quality Review reports.
- Create and present cGMP training to site personnel.
- Ensure current procedures are followed in connection with handling of complaint, recalls, returned goods, and reprocessing.
- Provide backup support to the Quality department.
- Perform additional tasks in relation to quality issues as agreed with the Quality Assurance Manager.
Qualifications
- Bachelor’s degree with greater than 5 years professional experience is highly preferred
- Knowledge of a cGMP production facility and/or inspection processes required
- 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
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 50 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally.
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 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.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
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