QA Specialist II (Validations)
PCI Services2d ago
This role ensures compliance with GMP standards within pharmaceutical operations. You will manage equipment qualification, process validation, and quality documentation.
LeónFluent Spanish
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91,000+ live jobsR&D Process Dev Chemist I
On-site in León·Full-time·Added 1 month ago (last checked 23 Oct)
PCI Services
13 open roles
Our summary
- Work mode
- On-site, León
- Contract
- Full-time
Visa options
The ad doesn’t mention sponsorship
Not a refusal, but not a yes. Worth asking in your first message.
Skills
This job advert was originally written in Spanish.
The role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
What you'll do
The Galenic Development Operator I will be responsible for performing all necessary laboratory-scale tests for formulation development, scale-up, and manufacturing process development. They will be responsible for the management of the Galenic Development laboratory. They will perform their duties in accordance with the GMP and FDA standards applicable to the target market, as well as with the company's internal quality criteria and procedures.
- Execution of the scale-up and validation process following established protocols.
- Experimental participation in the development and optimization of proposed formulas.
- Reporting the work performed to the Galenic Development Group Leader, Supervisor, and/or the Galenic Development Technician.
- Performing maintenance, calibration, and verification of the Galenic Development laboratory instrumentation.
- Supporting the Galenic Development Group in the manufacturing process when necessary. Engineering, clinical, exhibit, and process validation batches are managed by the Galenic Development Technician and supported by the Galenic Development Operator, who participates in all key points of the process.
- Collaborating with production personnel in manufacturing tasks when required by the company.
- Collaborating in the general management, order, and cleanliness of the Galenic Development laboratory.
- Collaborating in the training of apprentices.
- Performing their duties in accordance with the quality criteria and safety standards established by the company.
About PCI Services
In their own words
Additional information
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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