Computer System Validation Expert
Posted on Monday, April 24, 2023
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 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.
- 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:
- 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
- Thorough knowledge of quality management and CSV (GMP, 21 CFR Part 11, Annex 11, Data Integrity, GAMP5) aspects of computer system applications
- 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)
- Experience in international and multidisciplinary environments Operational knowledge and experience with IT systems and applications in a GxP environment
- Based in Barcelona or available to relocate to Barcelona without visa sponsorship
- Knowledge of cloud applications (CSV)
- 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
- Capable of working with a dynamic product that is ever-changing and evolving rapidly
- Excellent communication and negotiation (written, verbal, and presentation) skills, and advanced problem-solving orientation and decision making skills
- Strong analytical and creative problem-solving skills
- Ability to take smart risks and champion new ideas
- Team player, collaborative, innovative, get things done mind
- Ability to understand business and technical requirements.
- Show initiative in setting and meeting goals within an environment of managed change
- Ability to work under pressure, responsible for multiple vital tasks in parallel
- You take ownership and feel accountable for the product as a whole
- You don’t mind getting your hands dirty
- Commitment to quality
- You take responsibility for the success of the project
- Ability to evaluate risks, define and execute action plans and propose innovative solutions to solve problems
- Ability to work on multiple projects concurrently and prioritize resources
- Strong ability to motivate people and to negotiate win-win solutions in a matrix-oriented organization
- Strong interpersonal and leadership skills
- Proven ability to develop, present and justify positions to all levels within the company
- Demonstrates attention to detail and organizational skills
- Results-driven with a strong customer and quality focus
What we offer
- Full-time and permanent contract and immediate start
- Competitive salary in the sector
- Flexible schedule, intensive Fridays
- 16 weeks of gender-neutral Parental Leave
- Hybrid work
- An attractive individual Stock Option plan* in a high-growth company
- Flexible remuneration for transport and restaurant
- Language one-to-one training courses
- Private medical and dental insurance
- Internal training and certifications plan
- Career plan and scheduled salary reviews
- Team Building Activities
- Top-notch "tech pack" – We are Mac lovers
- An open and collaborative work environment with a young and dynamic team and international culture
- An opportunity for personal and professional growth, supported by high functioning, stellar investors and the exciting challenges that come with joining a company at the start of its growth trajectory
- A culture where your opinion is highly valued and appreciated
We are committed to providing an inclusive environment where all employees feel mutual respect and are contributing to the good of society. We are a group of creators with diverse backgrounds (over 23 different citizenships in our company) and are proud to be an equal opportunity workplace. All employment is decided based on qualifications, merit, and business needs. If you need assistance or accommodation due to a disability, you may contact us at email@example.com
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