Documentation and Compliance Manager
vor 5 Monaten
Beschreibung:
We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector.
Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT.
We make it GmbH places the highest demands on quality, ethics and discretion.
For our client, the company F. Hoffmann La Roche based in Basel, we are looking for an Documentation and Compliance Manager (M/F/d).
**Documentation and Compliance Manager (M/F/d)**:
**Background**
Within the department, the chapter Product Care/Documentation and Compliance is accountable for Technical Support of marketed Combination Products and Medical Devices, Post Launch Changes, Complaints and DHF Maintenance, input to APQR/PSQR, Remediation. The Documentation and Compliance activities include the departmental training concept and onboarding of new employees, SPOC for PQS and Quality systems, departmental archiving concept, records & data management and coordination of self-inspections/audits.
**Task and Responsibilites**
- Acts as a commercial complaint investigation support, evaluates the annual complaint analysis and supports follow up activities, for example, Root Cause Investigations, subsequent Corrective Action and Preventive Actions (CAPA) and Changes (Technical Change Management, Transfers, Capacity Expansion).
- Supports or leads technical Changes e.g. Design changes, Introduction of new therapeutic indications, establishing of additional suppliers, Vendor Initiated Change
- Manage the Product Care Annual Review (PCAR)
- Ensuring regulatory compliance and Roche internal GMP standards (e.g. departmental archiving concept, records management and training)
- Interpret Pharma Quality System requirements into local operational processes
- Support internal/external Quality/Regulatory/SGU inspections
- (Re-) Present PTDE-D in Project Teams, Quality Boards and Governance Bodies, as needed providing Subject Matter Expert (SME) expertis
- Continuous optimization of performance and striving for excellence
- Manage Onboarding of new employees and manage training system
**You must have these qualifications**
- Bachelor/Master Degree (Pharmacy, Pharmaceutical, Bioengineering, Chemistry or other relevant area) and first experiences in the pharmaceutical or a related industry (**)
- Demonstrated track record in project management (**)
- Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices (**)
- Experience with Health Authority interactions (**)
- Excellent communication and negotiation skills in German and English with success in building trustful relationships
- Self-motivated, proactive, responsible, result-oriented and an excellent team player
- Experience in working in agile environment and usage of lean tools
**Nice to haves**
- proven track record of compliance management and documentation in the pharmaceutical or
related industry
**Work hours**
- 40 h / Standard
**Are you interested?
-
Documentation and Compliance Manager
vor 5 Monaten
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: For our international medical partner, F. Hoffmann-La Roche Ltd. in Basel, we are looking for a qualified and motivated **Documentation and Compliance Manager** for a temporary contract of 12 months with a possible extension. Within the department, the chapter Product Care/Documentation and Compliance is accountable for Technical Support...
-
Documentation and Compliance Manager
vor 5 Monaten
Basel, Schweiz We make it GmbH VollzeitWe make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of competence in the personnel services sector. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the...
-
Process and Compliance Manager
vor 5 Monaten
Basel, Schweiz NTT DATA Vollzeit**Req ID**: 258136 We are currently seeking a Process and Compliance Manager to join our team in Basel, Basel-Stadt (CH-BS), Switzerland (CH). Overall, the role of the Data Migration Process & Compliance Manager is to: - Understand Data Migration Program strategy and associated defined processes. - Understand European, pharmaceutical industry, financial...
-
Process and Compliance Manager
vor 5 Monaten
Basel, Schweiz Hashmap Vollzeit**Req ID**:258136 We are currently seeking a Process and Compliance Manager to join our team in Basel, Basel-Stadt (CH-BS), Switzerland (CH). Overall, the role of the Data Migration Process & Compliance Manager is to: - Understand Data Migration Program strategy and associated defined processes. - Understand European, pharmaceutical industry, financial...
-
Compliance and Ethics Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz Bio-Rad VollzeitAbout the RoleThe EMEA Compliance Officer will serve as a trusted advisor to Bio-Rad workforce members and business partners operating within the region, assisting with the implementation of a compliance and ethics program in alignment with Bio-Rad's mission, vision, and values.Key ResponsibilitiesCollaborate with the Corporate Compliance team to identify...
-
Compliance and Ethics Manager
vor 1 Monat
Basel, Basel-Stadt, Schweiz Bio-Rad VollzeitJob Title: Compliance and Ethics LeadAt Bio-Rad, we are committed to advancing the discovery process and transforming the fields of science and healthcare. We are seeking a highly skilled Compliance and Ethics Lead to join our team in EMEA.About the Role:The Compliance and Ethics Lead will function as a trusted advisor to our workforce members and business...
-
Stability and Sample Manager
vor 3 Monaten
Basel, Schweiz ITech Consult Vollzeit**Stability and Sample Manager (M/F/d) - LIMS / GMP / German / English / Documentation** **Project**: For our client, a large pharmaceutical company based in Basel, we are looking for a **Stability and Sample Manager (M/F/d)** **Background**: We work with passion to improve the health and lives of patients. We show courage in our decisions and actions. And...
-
Statutory and Tax Compliance Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Lonza VollzeitJob OverviewLonza, a global leader in life sciences, is seeking a Statutory and Tax Compliance Manager to support the Head of BSO Finance.Key Responsibilities:Tax Compliance: Responsible for tax compliance and implementing and maintaining tax / transfer pricing strategy locally.Statutory Accounting and Compliance: Includes IFRS to local GAAP...
-
Nautical Compliance Manager
vor 1 Woche
Basel, Basel-Stadt, Schweiz Viking Vollzeitbody{font-family:Arial,sans-serif;}h1{color:#00698f;}Nautical Compliance ManagerViking is seeking a highly skilled Nautical Compliance Manager to join our River Operations team.Key ResponsibilitiesInvestigate incidents and near-misses, analyzing data and identifying root causes.Develop and implement safety management systems to ensure compliance with ISO...
-
QA Computer Compliance Manager
vor 6 Monaten
Basel, Schweiz Sobi Vollzeit**Company Description** At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Here at Sobi, our mission and culture get us...
-
MES Project Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Fusion Consulting VollzeitJob Title: MES Project Manager - Lead and DeliverWe are seeking a highly skilled and experienced Project Manager with a specialization in Manufacturing Execution Systems (MES). The successful candidate will manage the full lifecycle of an MES related project, including planning, execution, and documentation, as well as overseeing the integration of critical...
-
Nautical Compliance Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Viking VollzeitViking is seeking a highly skilled Nautical Compliance Manager to join our River Operations team. As a key member of our Nautical Operations department, you will be responsible for ensuring the highest standards of safety and compliance on our river voyages.The ideal candidate will have a proven track record in incident investigation and analysis, with a...
-
Project Manager Product Compliance
vor 5 Monaten
Basel, Schweiz Wingtra AG VollzeitJoin the Wingtra team and become part of this venture-backed robotics scaleup with a global and international team of 160+ dedicated Wingtranauts who want to see their actions have a positive and lasting impact on the world. Founded more than 7 years ago at ETH Zurich, Europe’s leading robotics university, our goal is to build the best aerial robots to...
-
Nautical Compliance Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Viking VollzeitViking is seeking a highly skilled Manager Nautical - Compliance to join our Nautical Operations River department. As a key member of our team, you will be responsible for ensuring the highest standards of safety and compliance across our river operations.The ideal candidate will have proven experience in incident investigation and analysis, with a strong...
-
Senior Manager of Quality Compliance
vor 3 Wochen
Basel, Basel-Stadt, Schweiz BeiGene VollzeitBeiGene is committed to getting more affordable medicines to patients worldwide. As a Senior Manager of Quality Compliance, you will play a critical role in ensuring the company's global compliance status with regulatory requirements.The role is part of the External Vendor Audit program, which aims to ensure BeiGene's compliance with applicable global...
-
Director - Ethics, Compliance, and Investigations
vor 5 Monaten
Basel, Schweiz Lonza VollzeitSwitzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...
-
Compliance Manager DACH Region
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Abbott VollzeitJob SummaryAbbott GmbH in Wiesbaden is seeking a Compliance Manager DACH Region to lead local compliance efforts within the biggest European Affiliate (Germany, Austria & Switzerland). The ideal candidate will have 6+ years of relevant work experience in Compliance and a strong understanding of the healthcare industry in the DACH region.Key...
-
Contract and Process Manager
vor 6 Monaten
Basel, Schweiz Coopers Group AG VollzeitContract and Process Manager For our Pharma client based in Basel, we are looking for a dynamic and experienced Contract and Process Manager. **Background**: Our client is looking for a Contract & Process Manager to join the Medical Affaire Team to support them with the increased workload. In this position, you will need to be able to work independently...
-
Contract and Process Manager
vor 5 Monaten
Basel, Schweiz Coopers Group AG VollzeitContract and Process Manager For our Pharma client based in Basel, we are looking for a dynamic and experienced Contract and Process Manager. **Background**: Our client is looking for a Contract & Process Manager to join the Medical Affaire Team to support them with the increased workload. In this position, you will need to be able to work independently...
-
Sr. Director, Ethics and Compliance
vor 5 Monaten
Basel, Schweiz Moderna Vollzeit**The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...