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- Aufgaben: Lead QA/Compliance efforts in a dynamic pharmaceutical environment, ensuring inspection readiness.
- Arbeitgeber: Join a leading pharmaceutical company in Basel, dedicated to quality and compliance.
- Mitarbeitervorteile: Enjoy a full-time role with opportunities for professional growth and a multicultural work environment.
- Warum dieser Job: Be part of impactful projects, enhance your leadership skills, and contribute to global compliance standards.
- Gewünschte Qualifikationen: Master's degree in biotechnology, pharmacology, or process engineering; 5+ years in GMP environments required.
- Andere Informationen: Fluency in English and German is essential; start date is October 1, 2023.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
For our customer, a big pharmaceutical company in Basel, we are looking for a highly qualified QA/Compliance Lead (m/f/d).
Background
The local QA/Compliance Lead is primarily to ensure appropriate local Aspire activities and deliverables meet QA/Compliance expectations and ensure compliance is maintained. Ultimately, the local lead will be accountable for ensuring the site is "inspection ready". The local Compliance Lead will work closely with core counterparts to understand the core deliverables and to ensure local compliance efforts are complementary to those produced on behalf of the wider programme. Locally, the Lead will ensure local change requests, protocols, CSV & quality deliverables, plans and reports are all completed in alignment with project plans/timelines and to ensure that any compliance risks are mitigated.
Tasks & Responsibilities
- Accountable for local CSV & Quality deliverables defined for the local Deployment
- Definition of local Change Request/Validation/Implementation plans (incl. CSV) and related closure/reports
- Accountable for the local implementation plan, local implementation interim report, local implementation report according to CSV requirements and the respective SOPs
- Coordinate and support adoption of local SOPs triggered by ASPIRE (i.e. definition of the SOP inventory, planning of SOP updates and coordination of SOP updates according to plan)
- Supporting the training activities for ASPIRE
- Supporting test planning, execution, closure and defects
- Supporting data migration, esp., local verification and incidents associated with GxP data
- Supporting local cutover activities to ensure all protocols are completed and deviations accepted
- Supporting any definition of interim ways of working required during cutover
- Defining and supporting any PQ activities if required
- Compliance support for defects, incidents and change controls
- Coaching and training of local ASPIRE team as required in related compliance approaches/deliverables
- Accountability for compliance, quality assurance, deliverable acceptance, and sign-off processes within the ASPIRE project
Must Haves
- Master Degree: With a successfully completed engineering degree in the field of biotechnology, pharmacology or process engineering, combined with the necessary specialist knowledge for this activity
- Min. 5 years experience in a GMP regulated manufacturing environment and with validation responsibilities
- Min. 3 years of experience in quality management in the technical and CSV qualification fields
- Extensive experience with the regulatory requirements in the GMP environment
- Experience in a matrix leadership role
- Compliance work within a project/change environment ideally experience in multi-site/global projects
- Understanding of ERP life cycle, deliverables and the compliance needs/implications
- Experience in previous deployment of global application to site is highly advantageous
- Fluent both in English and German (written/spoken)
- Excellent communication skills: The role requires clear direction locally, but also will involve global/above site engagement for both straightforward communication, and also influencing.
- Very Good x-functional understanding of compliance within a manufacturing site
- Ability to work in a matrix environment.
- Controlling/developing compliance deliverables and supporting other streams as appropriate
- Ability to understand the nature of risks and promote/support appropriate mitigations
- Coaching/supporting streams
- Ability to influence, esp. within a global team environment
- Ability to work within a multicultural environment
Reference Nr.
922882SDA
Role
QA/Compliance Lead (m/f/d)
Industrie
Pharma
Workplace
Kaiseraugst and Basel
Pensum
100%
Start
01.10.2023
Duration
21++
Deadline
17.09.2023
QA/Compliance Lead Arbeitgeber: Itcag
Kontaktperson:
Itcag HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: QA/Compliance Lead
✨Tip Number 1
Make sure to familiarize yourself with the specific GxP regulations and compliance standards relevant to the pharmaceutical industry. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards.
✨Tip Number 2
Highlight your experience in matrix leadership roles during networking opportunities. Connect with professionals in the field on platforms like LinkedIn, as they can provide insights and potentially refer you to the position.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed compliance risks in previous projects. Being able to articulate your problem-solving skills in a project/change environment will set you apart from other candidates.
✨Tip Number 4
Since the role requires fluency in both English and German, practice discussing technical compliance topics in both languages. This will help you feel more confident during interviews and show that you're ready for a multicultural work environment.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: QA/Compliance Lead
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the QA/Compliance Lead position. Understand the key responsibilities and required qualifications, especially the importance of compliance in a GMP regulated environment.
Tailor Your CV: Customize your CV to highlight your relevant experience in quality management, compliance, and matrix leadership. Emphasize your engineering degree and any specific projects that align with the requirements listed in the job description.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for the pharmaceutical industry and your understanding of GxP regulations. Mention specific experiences that demonstrate your ability to lead compliance efforts and manage change effectively.
Highlight Language Proficiency: Since fluency in both English and German is required, make sure to clearly indicate your language skills in your application. If you have experience working in bilingual environments, mention that as well.
Wie du dich auf ein Vorstellungsgespräch bei Itcag vorbereitest
✨Prepare for Compliance Questions
Make sure to brush up on your knowledge of GMP regulations and compliance requirements. Be ready to discuss specific examples from your past experience where you ensured compliance in a manufacturing environment.
✨Showcase Your Leadership Skills
Since the role requires matrix leadership, prepare to share instances where you've successfully led cross-functional teams. Highlight your ability to influence and coach others in compliance-related tasks.
✨Demonstrate Technical Knowledge
Be prepared to discuss your engineering background and how it relates to quality management and CSV. Show that you understand the technical aspects of the role and can apply them effectively.
✨Communicate Effectively in Both Languages
Since fluency in both English and German is required, practice discussing your experiences in both languages. This will demonstrate your communication skills and ability to engage with a multicultural team.
