Computer System Validation Expert

hace 4 semanas

Barcelona, España Aizon A tiempo completo

**Who we are**

Aizon is an AI software provider that transforms manufacturing operations using advanced analytics, artificial intelligence, and other smart factory technologies.
**Our mission is to improve global health in order to change patients’ lives**. We aim to do that by optimizing the way medicines are manufactured so that pharma and biotech companies can provide patients worldwide with the right medicine at the right time and at the right price. We are based in thriving San Francisco and sunny Barcelona, with customers and partners spanning the globe.

We are looking for new team members who share our values: trust, customer-centricity, innovation, integrity, collaboration, and passion.

We are embarking on an important journey, working to contribute to something impactful and new in the Life Sciences industry

**The Position**

The computer System Validation Expert will provide expertise in ensuring that Aizon’s AI Platform and developed products are ready for regulatory compliance within the framework of all current applicable regulations (GxP, 21 CFR Part 11, etc.), expectations, and defined requirements. Will provide Regulatory Compliance oversight regarding the software development lifecycle and Computer System Validation activities such as writing, reviewing, and updating the required Validation package deliverables to maintain a validated state of control.

**Responsibilities**:

- Reviews the Software Requirements, Functional Specifications, and Design Specifications for the developed products as part of both the internal and the client’s Validation packages as well as the IQ, OQ, and PQ protocols
- Writes the Risk assessment and the validation report for each testing phase, as well as the final validation report for the Aizon AI platform and products.
- Advises and assists in creating the Quality Control deliverables that are part of the Product Validation Process (Test strategy, test plan, test cases/expected results) and provides a compliance oversight over the generated test evidence to fulfill internal and external requirements.
- Advises and reviews the test cases defined according to the testing strategy in each phase of the validation process.
- Writes the validation reports for each validation phase and the final validation report for the developed products.
- Maintains the traceability matrix updated for the developed products.
- Reviews all the CSV validation activities, including deliverables, from a regulatory compliance standpoint.
- Ability to provide guidance on revising validation documents and protocols.
- Informs product owners and management of potential areas of risk and provides guidance on Computer System -Validation (CSV) detected validation gaps, issues, and discrepancies if any.
- Support investigation of CSV defects and quality records (deviations, corrective actions, preventive actions).
- Provides support to external and internal audits related to computerized system validation activities (QA, ISO, customer).
- Contributes to projects related to CSV or compliance improvements.
- Helps, establishes, and sustains Aizon’s computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
- Provide direct oversight for computer system validation from a quality assurance compliance perspective to meet quality regulatory and compliance requirements.
- Advises a cross-functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations and accomplish goals throughout timelines.
- Advising and /or revising SOPs related to software development lifecycle.
- Advise on the administration of all applicable electronic systems.
- Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.

**Knowledge and experience**:

- ** Must-have**:

- Bachelor of Science in IT, Chemistry, Pharmacy, Biology, or related science or technical field
- Between 2 and 5 years experience in the biopharmaceutical regulated industry (FDA, EMA) with expertise in either Quality Assurance, Quality Management, IT Compliance, or equivalent
- Proficient in spoken and written English
- Demonstrate proficiency and thorough knowledge of computer system validation (CSV) requirements defined by applicable authorities and/or industry groups
- Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5
- Good knowledge of regulatory requirements (FDA, EMEA, ICH)
- **
Nice-to-Have**:

- Knowledge of Amazon Web Services (desirable)
- Experience in working on SaaS System Validation is desirable
- Experience with electronic Batch Record software
- Knowledge of Agile methodologies & iterative software development

**Skills**:

- Capable of working with a dynamic product that i

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