Validation Specialist, On-site

_Do you want to work with a collaborative, diverse team and gain innovative experience in one of the fastest evolving industries?_

SRx health solutions is a fast-growing healthcare solutions services company designed for today’s growing markets. We are Canada’s leading provider of innovative, sustainable, and integrated healthcare solutions on a mission to enhance the wellness of Canadians. You will be part of a team dedicated to creating immersive experiences and transforming ideas into successful health care programs that matter.

We offer a truly inspiring and flexible work environment. Here, you will be empowered to follow your passion to continuously learn and grow. Not to forget to mention, we have one of the friendliest teams on the globe

**About the role**:
The Validation Specialist will be responsible for leading the validation and qualification activities at SRx Health including packaging/ shipping lane studies, computerized systems (i.e. SAP and Quality Management Systems) and facility/equipment. The Validation Specialist will be responsible for evaluating and managing execution qualification and validation activities while maintaining cGMP compliance and all applicable regulations related to validation at SRx Health.

**Roles & Responsibilities**:

- **This role is not a Quality Assurance role.**:

- Lead validation/qualification/calibration activities such as transportation shipping lanes, temperature mapping, equipment qualification, and computerized systems validation
- Develop, write, review and lead execution of validation and qualification protocols, user acceptance test (UAT) scenarios, and procedures on an ongoing basis to ensure regulatory compliance to established internal and external criteria for cold chain/ambient packaging, computerized systems, equipment, and premises, as applicable.
- Prepare validation/qualification reports as required including preliminary analysis, final analysis and recommendations.
- Work closely with cross-functional teams including Operations, Quality Assurance, and external vendors (when required) to evaluate solutions, troubleshoot and resolve validation/qualification issues
- Identify, investigate, and resolve deviations associated with or impacting validation/qualification, perform risk assessment for business/GMP impact
- Manage and maintain the equipment, premises and computerized systems in a qualified and calibrated state.
- Lead GMP equipment preventative management activities, including tracking calibration and maintenance events, and coordinating equipment servicing contractors.
- Review equipment specifications, manuals, and develop an understanding of how equipment functions
- Develop and maintain a validation and project schedule to ensure timely completion of validation/qualification activities
- Assist during audits from regulatory authority, internal, and external parties
- Keep up-to-date with industry standards and regulatory requirements related to validation and qualification

**Job Specifications & Qualifications**:

- Bachelor’s degree in Engineering (biochemical, mechanical), or Life science or related field
- 3 years of relevant validation and qualification experience within a pharmaceutical environment. 1 year experience with transportation shipping studies/ shipping lanes.
- Demonstrated experience with Canadian GMP requirements, harmonized international guidelines (PIC/S, ICH), and other applicable regulations/guidelines pertaining to GUI-0069 and validation of computerized systems.
- Experience with pharmaceutical supply chain operations with emphasis on shipping packaging/ computer systems, and facilities/equipment
- Quality Assurance experience would be an asset
- Ability to work independently and as part of a team
- Strong attention to detail & excellent interpersonal skills
- Excellent analytical and problem-solving skills with ability to make fact-based decisions.
- Solid organizational skills with the capacity to prioritize and multitask.
- Strong computer skills including Microsoft Office Suite, specifically Excel

**What we offer**
- Paid vacation, public holidays
- Paid sick days
- Opportunities to develop new skills and progress your career
- Specialized training
- Competitive salary with comprehensive benefits package.
- RRSP matching
- Annual Bonus
- **If it sounds like you, we want you to apply**_

**About us**

SRx Health Solutions was founded in 2013 by its current President, Adesh Vora. After running retail pharmacies for over 12 years, Mr. Vora opened two pharmacies in Ontario. From the onset, the focus was to provide specialized healthcare solutions for Canadians. To achieve this, Mr. Vora recognized the need to provide more than just retail pharmacy services.

SRx was founded in Ontario in 2013 and today has over 300 employees across Canada.

**Job Types**: Full-time, Permanent

**Salary**: $65,000.00-$85,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Flexible schedule
- On-s