QA Specialist
vor 4 Wochen
Job Description
Quality Assurance Specialist, Quality Assurance Post-Approval
Job Summary:
The QA Specialist, as a member of the QA Post-Approval team, is responsible for the quality review and approval of executed batch records, certificate of packaging and supporting documentation according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs).
The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) is able to provide according to FCS quality standards and timelines. After appropriate training, the QA specialist is able to complete the tasks in Key Duties & Responsibilities chapter. Different tasks can have different training requirement and the QA specialist needs to be qualified.
Responsibilities:
Review of executed batch records, creation of certificate of packaging
Support QA Pre-Approval as required by line manager/workload: Review and quality approval of pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labelling requests, job specifications, packaging orders, LINKS reports, randomizations, SPA and supporting documentation
Liasing with project managers to ensure the above mentioned documents are according to customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs)
Coordination and internal communication regarding the scheduling and completion of the documentation reviews and approvals
Supply of information internally regarding the documentation review and approval process to support project planning
Provide support to improve documentation right first time metrics
Ensuring any deviations or quality issues are appropriately documented
Inputting or analysing data for quality metrics
Inform Supervisor of quality issues
Maintain accurate records for all work activities
Training and introduction for new team members and for other FCS departments (e.g. CS, CSOS etc.)
Organising/executing/documenting GMP document archival (internal/external)
Provide support for the larger Quality department which may include tasks such as:
Participation in Practical Process Improvement or other projects
Review and disposition decisions according to the agreed customer process for transport deviations and temperature excursions
Supporting the review and approval of Pharma Unit Trackwise problem reports (PRs)
Acting as a customer quality contact, answering client questions with regards to executed batch records
Qualifications:
Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, scientific field or equivalent
GxP training or experience
Demonstrated ability to perform detail-oriented tasks
Bachelor’s degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific role
Excellent communication and organizational skills
High level of accuracy and efficiency
Ability to express detail in simple terminology, both written and verbal
Command of English and German at professional level
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
-
QA Specialist
vor 4 Wochen
Allschwil, Basel-Land, Schweiz ThermoFisher Scientific VollzeitJob DescriptionQuality Assurance Specialist, Quality Assurance Post-ApprovalJob Summary:The QA Specialist, as a member of the QA Post-Approval team, is responsible for the quality review and approval of executed batch records, certificate of packaging and supporting documentation according to customer and regulatory requirements (including Good Clinical...
-
QA Specialist
vor 17 Stunden
Allschwil, Basel-Land, Schweiz Thermo Fisher Scientific VollzeitWhen you're part of Thermo Fisher Scientific, you'll discover impactful work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the...
-
QA Specialist
vor 1 Woche
Allschwil, Schweiz Thermo Fisher Scientific VollzeitWhen you’re part of Thermo Fisher Scientific, you’ll discover impactful work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the...
-
QA Specialist
vor 2 Monaten
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Review of executed batch records, creation of certificate of packaging Support QA Pre-Approval as required by line manager/workload: Review and quality approval of pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labelling requests, job specifications, packaging orders, LINKS reports,...
-
Allschwil, Basel-Land, Schweiz Idorsia Pharmaceuticals Ltd VollzeitPress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Director, Commercial Affiliate QA GMP GDP and Qualified Person Location: Basel, BS, CH About Idorsia Pharmaceuticals LtdIdorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.In order to achieve this,...
-
Quality Assurance Manager
Vor 6 Tagen
Allschwil, Schweiz SKAN AG VollzeitFounded in 1968, **SKAN** is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories. Overview We are looking for an energetic addition to our...
-
Customer Service Specialist I
vor 1 Monat
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Management of purchase orders to comparator suppliers Generate BB-Nos. and product specifications Double check content of documents received in order to issue Purchase Order to suppliers in GPM and/or Coda Administrate purchase orders in Salesforce, set the correct status and monitor delivery times of the Purchase orders Ensure effective...
-
Customer Service Specialist I
vor 2 Wochen
Allschwil, Schweiz Thermo Fisher Scientific Vollzeit: Management of purchase orders to comparator suppliers Generate BB-Nos. and product specifications Double check content of documents received in order to issue Purchase Order to suppliers in GPM and/or Coda Administrate purchase orders in Salesforce, set the correct status and monitor delivery times of the Purchase orders Ensure effective...
-
Customer Service Specialist I
vor 16 Stunden
Allschwil, Basel-Land, Schweiz Thermo Fisher Scientific Vollzeit: Management of purchase orders to comparator suppliers Generate BB-Nos. and product specifications Double check content of documents received in order to issue Purchase Order to suppliers in GPM and/or Coda Administrate purchase orders in Salesforce, set the correct status and monitor delivery times of the Purchase orders Ensure effective...
-
Quality Assurance Manager
vor 13 Stunden
Allschwil, Basel-Land, Schweiz SKAN AG VollzeitFounded in 1968, **SKAN** is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organisation have made SKAN a market leader and a key partner to industry and research laboratories.OverviewWe are looking for an energetic addition to our...
-
Comparator Project Manager Ii
vor 4 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $50 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...
-
Client Services Project Manager Ii
vor 2 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $50 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...
-
Client Services Project Manager Ii
vor 16 Stunden
Allschwil, Basel-Land, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $50 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...
-
Associate Project Manager Comparator
vor 3 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitWhen you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world The Comparator Associate Project...
-
Associate Project Manager Comparator
vor 2 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitWhen you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world The Comparator Associate Project...
-
Associate Project Manager Comparator
vor 2 Wochen
Allschwil, Schweiz Thermo Fisher Scientific VollzeitWhen you join us at Thermo Fisher Scientific, you’ll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the worldThe Comparator Associate Project...
-
Associate Project Manager Comparator
vor 13 Stunden
Allschwil, Basel-Land, Schweiz Thermo Fisher Scientific VollzeitWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the worldThe Comparator Associate Project...
-
Client Services Project Manager I
vor 1 Woche
Allschwil, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $50 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,...