In this role, you manage quality control processes and support project implementation, ensuring compliance and effective communication across teams. You also coordinate with external partners and lead continuous improvement initiatives.
Anforderungen
- •Master's degree in relevant field
- •Significant experience in pharmaceutical industry
- •3-5 years lab experience in QC methods
- •At least 5 years in GMP environment
- •Experience in project and task coordination
- •Business insight and critical thinking
- •Emphasis on achieving goals
- •Effective communication skills
- •Strong collaboration abilities
- •Agility and adaptability in ambiguity
- •Proficiency in English and German
Deine Aufgaben
- •Coordinate processes for testing finished products and materials.
- •Write and revise standard operating procedures and work instructions.
- •Review and approve methods, plans, protocols, and reports.
- •Support procurement and maintenance of analytical equipment.
- •Coordinate development and validation of analytical procedures.
- •Review analytical raw data and documentation in Biochemical QC.
- •Represent BCQC in projects and local/global initiatives.
- •Promote effective communication within project teams.
- •Support project implementation and data-driven workload management.
- •Drive project collaboration aligned with company values.
- •Own problem-solving for assigned projects and tasks.
- •Coordinate resources to meet QC timelines and targets.
- •Promote an accountable working environment through mentorship.
- •Support continuous improvement of QC compliance and performance.
- •Establish contact with external partners and suppliers.
- •Document and deposit raw data, results, and reports.
- •Assist in resolving issues related to (bio)chemical analytics.
- •Ensure timely investigation of deviations.
- •Communicate ongoing business and issues to BCQC head.
- •Share information with sponsors, customers, and colleagues.
- •Support QC colleagues in GMP and Quality Control.
- •Assist with team recruitment efforts.
- •Act as liaison for departmental teams and DI officer.
Original Beschreibung
# Senior Scientist Bio-/Chemical Quality Control
**Lengnau, Switzerland** | **Full time** | **Fully Onsite**
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
## Technical Responsibilities
**Processes and methods implementation:**
* Coordinate actions to establish and implement processes and analytical methods for testing finished products, in-process controls, intermediates, raw materials, utility, and cleaning samples.
* Responsible for:
* Write and revise standard operating procedures (SOPs) and work instructions (Wis) within timelines
* Review and approve methods, plans, protocols, and reports
* Supporting procurement, qualification, calibration, and maintenance of analytical and infrastructure equipment
* Coordinate the development, transfer, and validation of analytical procedures according to given timelines
* Review of analytical raw data, equipment qualification/maintenance raw data, and other documentation in Biochemical QC.
## Project Leadership:
* Represent BCQC in projects, workgroups, and participate in local and global initiatives
* Promote effective and timely communication within project teams, ensuring visibility and understanding of the site/company's strategy
* Support project implementation within the QC department and ensure data-driven workload for each assigned project
* Drive project collaboration and operate in full alignment with the company's core values
* Own the problem-solving process for any issues related to assigned projects/tasks
* Coordinate resources in collaboration with the rest of QC, ensuring QC timelines and targets are met
* Promote an accountable working environment through management mentorship and open access to important information
* Proactively support continuous improvement of QC compliance and performance
* Establish and maintain contact with external partners such as suppliers, contract laboratories, and universities
## QC Execution:
* Document and deposit raw data, results, reports, and journals
* Assist during the resolution of issues and requests related to (bio)chemical analytics (quality issues, health authority requests, etc.)
* Ensure timely investigation of deviations
* Communicate efficiently and inform the head of BCQC about ongoing business and issues
* Sharing required information with sponsors, customers, and colleagues
* Supporting QC colleagues in the areas of GMP and Quality Control
* Supporting recruitment within the team
* Acting as liaisons between their respective departmental teams and the DI officer, ensuring regular DI Surveillance and performing internal DI moments, huddles, and trainings
## Position Qualification
Education:
* Degree or equivalent experience (Master or higher) in biochemical, chemical, pharmaceutical, molecular sciences, or similar fields.
* Lower educational background may be accepted based on significant experience in the pharmaceutical industry.
## Experience & Proficiencies:
* 3-5 years lab experience with confirmed expertise in (bio)chemical QC methods, method validation, and analytical issue management
* confirmed experience (at least 5 years) in chemical or biochemical laboratories, including experience in a regulated GMP environment
* experience in project and task coordination
## Proficiencies:
* Business insight and critical thinking
* Emphasis on achieving goals and taking ownership
* Effective communication skills
* Strong collaboration abilities
* Agility and adaptability in handling ambiguity
## Additional Requirements:
* Proficiency in English and German is required, with exceptions considered on a case-by-case basis based on the overall CV.