Validation Specialist Trainee

OPTEL. Responsible. Agile. Innovative.

OPTEL is a global company that develops transformative software, middleware and hardware solutions to secure and ensure supply chain compliance in major industry sectors such as pharmaceuticals and food, with the goal of reducing the effects of climate change and enabling sustainable living. If you are driven by the desire to contribute to a better world while working in a dynamic and collaborative environment, then you've come to the right place!

Validation Specialist Trainee

SUMMARY

The Validation Specialist is responsible for creating and maintaining validation documents, such as internal validation protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Change Controls, to ensure that Optel systems comply with industry standards. This role requires expertise in documentation and the ability to collaborate with internal teams and clients to ensure project validation and quality control.

RESPONSIBILITIES

Validation documentation and management:

• Develop and maintain standardized validation templates for internal use and for clients that comply with industry standards and regulatory guidelines, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11.
• Review and understand system updates, including new releases and hotfixes, to determine the impact on validation documents.
• Generate validation documents for clients based on the functional and design specifications of the projects.
• Execute internal validation protocols as needed to ensure system functionality.
• Act as a resource person at the documentary level (URS, FS, DS, Test plan, etc. )
• Provide Necessary Change Control Documents as per customer requirements.
• Author Factory Acceptance test, Site Acceptance Test documents.
• Support internal Teams and customer on Queries related to Validation documents
• Author and support Onsite Qualification Documents such as IOQ, Trace matrix etc.

Risk Analysis and Quality Improvement:

• Identify potential risks associated with validation activities and develop mitigation strategies.
• Lead root cause investigations for validation discrepancies and implement corrective actions for continuous quality improvement.

Collaboration and Expertise:

• Collaborate closely with the internal team and clients to provide expert guidance on validation strategies and best practices.
• Work closely with the quality assurance (QA) team to ensure that validation activities are in line with internal quality systems and external regulatory requirements.
• Partner with various internal departments to deliver validation documentation at specific stages of project development.

Related Tasks:

• Perform any other tasks related to validation processes.

SKILLS AND QUALIFICATIONS REQUIRED

• College diploma in a relevant field.
• Excellent proficiency in English (written and spoken).
• Advanced knowledge of the Microsoft Office suite.

EQUAL OPPORTUNITY EMPLOYER

OPTEL is an equal opportunity employer. We believe that diversity is essential for fostering innovation and creativity. We welcome and encourage applications from individuals of all backgrounds, cultures, gender identities, sexual orientations, abilities, ages, and beliefs. We are committed to providing a fair and inclusive recruitment process, where each candidate is evaluated solely on their qualifications, skills, and potential. At OPTEL, every employee's unique perspective contributes to our collective success, and we celebrate the richness that diversity brings to our team.