Senior Quality Assurance Specialist
ProClinical is seeking a Senior Quality Assurance Specialist to be based in Geneva on a permanent basis. The Senior Quality Assurance Specialist will be responsible for maintaining all documents and requirements for a local drug establishment license (DEL); reviewing and approving executed batch records of finished drug product for release to market; management of samples/records; managing reference standards and retain samples; and assist with drafting product quality reviews. They will assist in development of procedures, coordinating Change Controls, CAPAs, Deviations and Complaints. The incumbent will also assist with QA Review coordination and maintaining the training program file, administrating SOPs as assigned. The incumbent will also assist the Quality Assurance department with other duties, as directed.
- Maintaining DEL documentation and requirements.
- Review and approval of finished drug product batch records for release to market.
- Develop a process to manage samples and documentation. Manage the samples and documents both off-site and on site in line with changing company needs.
- Reference standard management.
- Retain sample management.
- Assist in reviewing and drafting Product Quality Reviews.
- Drafting and/or reviewing Standard Operating Procedures, specifications.
- Assist in coordinating Change Controls, CAPAs (Corrective and Preventative Action), Deviations and Complaints.
- Coordinate and perform QA review of regulatory submissions, labelling/artwork and promotional materials.
- Ensuring the QMS procedures are followed. Specific activities include:
- Receive, assemble information related to Change Control, Complaints, CAPA, and Deviations; and notify stakeholders (i.e. internal personnel, contractors, external parties); and request relevant information/feedback. Follow-up as necessary, obtain approvals and create comprehensive reports including the supporting documents and communications. Archive all reports both electronically and in hard copy.
- Assist with development/improvements to workflows for quality processes.
- Assisting with developing and implementing written procedures for optimizing quality processes
- As directed: draft, facilitate, manage, schedule, track and/or follow-up on the content, review cycle and/or approval cycle of any required documentation, records or materials (i.e. promotional material).
- Assist with ensuring that all employees training records are up to date, according to the company's procedures.
- Assist the SOP Administrator with document management activities as assigned.
- Other duties as assigned.
Skills and Requirements:
- University degree, preferably with a science background.
- At least 7 years of Quality Assurance experience in the pharmaceutical industry.
- Excellent attention to detail and computer skills, such as Microsoft Office Suite of products and ability to learn new computer software programs.
- Highly developed organizational skills and a track record of using personal initiative in developing new projects.
- Demonstrated ability to work both independently and as part of a multidisciplinary team.
- Excellent oral and written communication skills.
- Ability to manage multiple tasks with competing priorities.
- Must be able to work flexible hours potentially including evenings and weekends on occasion
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Josh Volpe on +44 203 800 1292 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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