QA & CSV Analyst

Let’s Build the Next Industrial Revolution Together

Behind every product is a person

At Vimachem, we’re using technology to empower the people who manufacture medicines for our world. This is why we are developing the world’s biggest manufacturing intelligence AI Cloud specifically for Life Sciences incorporating AI, IIoT and Industry 4.0 technologies, allowing pharmaceutical and biotech manufacturers to scale faster with greater flexibility.

About the role

We are looking for a QA & CSV Analyst to join our Quality Assurance team and play a key role in ensuring the integrity, compliance, and validation of our software products.

As part of the QA team, you will work closely with both technical and regulatory teams to ensure our products meet rigorous industry standards and comply with all relevant regulations, particularly in the pharmaceutical and life sciences sectors.
You will be responsible for driving the validation of software systems (CSV), performing detailed testing, and ensuring that the software performs with the highest quality and reliability.

We are looking for someone with a strong attention to detail, who is proactive in identifying issues and collaborating with cross-functional teams to implement solutions that maintain the highest level of compliance, quality, and customer satisfaction.

What will you do as a QA & CSV Analyst?

• Validation Execution (IQ/OQ) during the Implementation of software solutions to our customers.

• Participate in the generation & execution of various GMP documents and protocols, including URS, FRA, FS/DS, IQ, OQ & PQ.

• Assist in maintaining our Quality Management System.

• Assist in developing SOPs and quality policies.

• Assist in the audit, review, development, and implementation of computerized systems to assure they meet the required standards of quality and compliance.

• Participate in the creation, revision and implementation of IT-related policies or procedures.

• Assist with queries regarding computer systems operation, development and validation during regulatory and due diligence inspections.

• Collaborate closely with other team members to deliver value to our customers.

• Work with other distributed teams to drive the quality strategy of our products.

The main qualifications for this QA & CSV Analyst role are: 

• Bachelor's degree in a technical or health-related field is preferred.

• Minimum 2 years of experience in QA & CSV related activities. Experience within a Pharmaceutical Manufacturer will be preferable.

• Experience with writing SOPs and QA processes is required.

• Understanding of GMPs, GAMP, EU Annex 11, 21 CFR Part 11, and current industry / EU / FDA compliance is required.

• Knowledge and familiarity with Computerized Systems Validation – Legislation.

• Testing experience in a regulated environment is a plus.

• Excellent written and verbal English communication is required.

Working At Vimachem: 

We are building a strong, diverse team that values hard work, families, and personal well-being. 

Benefits of working with us include:

• Bonus scheme.

• Employee Stock Option Plan (ESOP).

• We offer a hybrid or fully remote working environment with utmost flexibility.

• Benefits package including Health insurance, Life insurance, Short-term Disability, and Long-term Disability.

• Monthly allowance for lunch expenses.

• Continuous training.

• A buddy will support you with onboarding.

• Latest tech in laptop.

• Company events and free office snacks.

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Help us build an inclusive community that will transform manufacturing.