Senior Validation Specialist Jobs

The Company
BioPharma Services Inc. is a subsidiary of Think Research.
BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.
Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.
It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.
Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.
Why Us?

• It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact!
• Collaborative, creative, dynamic and flexible work environment, with a start-up spirit
• Everything we do – and we do it with passion – is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
• We’re growing, and so will you with leaders who will support your development through mentorship and other opportunities

The Role
Responsible for developing/maintaining the validation program at BPSI for computer systems, equipment and processes used at BPSI for the conduct of clinical trials and bioanalytical assays. Lead the validation team on validation projects. Works directly in partnership with business management to address business issues.
You Will Have The Opportunity To:

• Ensure compliance with appropriate SOPs/Protocols, GCP ICH guidelines, 21 CFR 11 and GAMP 5 for computer validated systems.
• Lead the validation activities in the execution of validation project deliverables.
• Develop and implement validation IQ/OQ/PQ strategies for computer system, equipment and process validation.
• Prepare validation plans including qualification protocols (IQ/OQ/PQ) and test scripts for computer systems (Watson LIMS, Analyst Software etc.).
• Execute other duties as may be required by the site specific management level and other members of the Corporate IT team.
• Works with the Quality Assurance group in the development/revision and implementation of Standard Operating Procedures as required.
• Oversee and approve change control procedures and re-validation activities.
• Assess new and legacy systems for compliance with GxP requirements.
• Ensure the site validation program meets FDA and EU requirements as well as GxP guidelines.
• Responsible for overseeing specialized IT systems (Sciex Analyst® Software, SoftMax Pro) and any newly acquired software systems (e.g. Watson LIMS).

What You Will Bring:

• Knowledge of FDA and EU GMP, GCP and GAMP regulations
• Strong attention to detail.
• Strong written and verbal communications skills.
• Demonstrated technical understanding of Microsoft operating systems, PC based application software and other related technologies.
• Bachelor’s degree in scientific or technical field or equivalent and extensive computer related training courses or experience.
• Ability to manage multiple priorities and coordinate workload.
• Customer service oriented.
• Excellent analytical and problem solving skills with solid organizational skills with the capacity to prioritize and multitask.

Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment.
We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs.
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