Job Description:
Job Title: Expert in Visual Manufacturing Control (m/f/d) – GMP/Pharmaceutical Production, Development, or Quality Assurance / IT Systems / Trackwise / Veeva / German and English
For our client, a leading pharmaceutical company based in Kaiseraugst, we are seeking an Expert in Visual Manufacturing Control (m/f/d).
Background:
Pharma Technical Development Europe Biologics (PTDE) brings groundbreaking therapies from clinical phases to market, serving every patient, every day. Our core business involves developing safe, innovative, and effective medicines using state-of-the-art technologies for manufacturing processes (active substance and drug product), clinical supply, formulation, packaging, and analytical development. The Drug Product Clinical Supply Center (Parenterals) (PTDE-C) in Basel is responsible for the production and filling of sterile dosage forms from the global research and development portfolio. "State of the art" manufacturing facilities are available on-site in Basel for supplying clinical studies in Phase I–III within a modern building.
The perfect candidate has completed vocational training with a scientific background and has more than 3 years of experience in pharmaceutical production. Additionally, the candidate is adept at using IT systems and possesses excellent proficiency in both spoken and written German.
Main Tasks and Responsibilities:
- GMP-compliant visual inspection and documentation of sterile clinical test preparations for parenteral application in various forms (Lyophilized and liquid vials, prefilled syringes, and cartridges).
- Preparatory and follow-up tasks (e.g., cleaning, line clearance).
- Sample retrieval, visual inspection, and sample control, working closely with logistics for sample handover.
- Processing goods in the MES, warehousing, and retrieval of goods.
- Replenishment of residual containers, generation of acceptable goods, and preparing goods for shipping in accordance with internal guidelines.
- Workplace cleaning, working according to 5S principles.
- Conducting leak tests of media fills.
- Conducting qualifications.
- Conducting practical training/onboarding.
- Support during audits and inspections.
Additional Responsibilities Include:
- Responsibility for assigned equipment.
- Updating the process tracking tool (Smartsheet), assisting with detailed planning, coordinating visual inspection.
- In-depth specialized understanding, maintaining and expanding specialized knowledge, acting as a contact person for specialized queries.
- Process-related changes, deviations, and general troubleshooting in the applicable Quality System (Veeva) (e.g., initiating unplanned events, processing actions).
- Subject Matter Expert (SME), authorship, cooperation for PQS documents (e.g., SOP).
- Collaboration within the CSC and with relevant internal and external interfaces, as well as teamwork skills.
Must-Haves:
- Completed vocational training, Bachelor's or Master's degree, or a comparable qualification with a scientific or technical background (Pharmacy, Biosciences, Natural Sciences, Engineering, Pharmaceutical Manufacturing, etc.).
- Minimum 3 years of experience in pharmaceutical production, development, or quality assurance; associated extensive knowledge and experience in the visual inspection of parenteral products.
- Proficient use of IT systems, e.g., Condor, Trackwise, Veeva, Google Suite (gSheet, gDoc, gDrive), Smartsheet, MES, Microsoft Office.
- Excellent German language skills in both spoken and written.
- Positive, solution-oriented, Can-Do attitude.
- Strong team skills.
- Open and agile mindset, recognizing changes as opportunities in a constantly evolving environment.
- Ability to work independently, take responsibility.
- Open Speak-Up and error culture.
- Great interest in process-related workflows and enthusiasm for visual inspection.
- Willingness and curiosity to develop further and contribute cross-functionally.
Nice-to-Haves:
- Good English language skills.
Reference No.: 922919SDA
Role: Expert in Visual Manufacturing Control (m/f/d)
Industry: Pharmaceuticals
Location: Kaiseraugst
Workload: 100%
Start: ASAP
Duration: 12++
Application Deadline: 25.10.2023
If this position has piqued your interest, please send us your complete dossier via the link in this ad. If this position doesn't align well with your profile and you wish to receive other positions directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for further information about our company, our positions, or our attractive payroll-only program: +41 41 760 77 01.
About Us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. We specialize in the placement of highly qualified candidates for temporary employment in the fields of IT, Life Science, and Engineering. We offer temporary employment and payroll services. For our candidates, this is free of charge, and even for payroll, we do not charge any additional fees.
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