Validation Manager
Ian Martin Executive - Charlottetown, PE

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Ian Martin Executive provides strategic talent acquisition services for human and animal health care organizations across Canada. As a preferred Canadian partner, there is a great opportunity for a Validation Manager to join an exploding pharmaceutical health care business located in a beautiful area with a view of the ocean.

Focused within a very niche but advancing market, this industry is a promising field for the future. Bottom line: develop, scope and build the validation master plan; the foundation for the department and overall business with the goal of expanding the team over the next 1 to 2 years.

Objective

The Validation Manager ensures systems and operations are compliant with regulatory and Company requirements through preparation of risk assessments, preparation and execution of validation protocols and final reports. There will be a significant priority to process data analysis, driving continuous process improvement in manufacturing and driving the validation processes forward by managing, scheduling, execution, and supervision of staff who are involved in assisting protocol execution and whose primary responsibility is to validate equipment and processes.

Accountabilities

- Development and execution of protocols and quality risk assessments (i.e. Process validation, Cleaning validation, Equipment qualification, Product validation, and Sterilization validation).

- Responsible for initial and annual requirements such as gowning qualification of personnel, media fills, temperature mapping and heat penetration studies.

- Documentation and remediation of deviations resulting from validations/qualifications.

- Develop and utilize established protocols to perform validation and qualification tests and provide detailed and accurate analysis of test results, process capabilities, FMEA/Risk analysis, identifying and investigating validation failures/complaints and trend analysis to access areas of non-conformance

- Prepare and update SOPs

- Trouble-shoot and provide guidance, recommendations for solutions for identified validation and qualification issues based upon sound and knowledgeable analysis.

- Schedule the necessary qualifications/requalification’s with minimal impact on the manufacturing schedule.

- Produce validation reports as required including statistical analysis, results analysis and observations.

- Provide assistance and guidance in training co-workers on validation protocols and operating procedures.

- Remain current on legislative, regulatory and technical changes within the industry

- Manage the maintenance of the validation equipment in a qualified/calibrated state

Requirements

- B.S. Engineering or Science Degree Diploma

- 4 – 10 yrs proven record of Equipment/Process Validation

- High proficiency in Word Processing

- Working Knowledge of cGMPs

- Experience working with multi-disciplinary teams

- Advanced communication skills

- Advanced problem solving skills.

Location

- Live and work in Canada in a picturous area close to the ocean.

- Support for relocation will be provided. Professionals from Canada or USA would be ideal.

If you are an experienced Validation Manager/Supervisor/Senior Specialist or ready for the next step in your career, please submit your resume. Only applicants with those most aligned with the business needs of the client.

IAN MARTIN EXECUTIVE ORGANIZATION

About The Ian Martin Group

Founded in 1957, the Ian Martin Group is one of North America’s leading consulting and project recruitment firms. As a Certified B Corporation (http://bcorporation.net/), our company meets comprehensive standards that measure our impact on employees, suppliers, the community, and the environment. Our guiding statement is: "building authentic connections around meaningful work."

The Ian Martin family includes Ian Martin Executive, our technical recruitment divisions IME, IMT and IMIT – experts in engineering, telecom and information technology respectively – and The 500 Staffing Inc., which is best understood as 'not so' general staffing. Our newest division, Granary, connects people who seek to drive positive net impact through their work.

About Ian Martin Executive

Ian Martin Executive was formed to share a unique Investigative Approach and offer this process to our clients across the country. Our approach is simple: strong, fair and unpretentious, striving to elevate and surpass expectations.

Many retained search firms specialize in vertical markets. We are different. Our Investigative Approach is in-depth, so it requires trust. Therefore, we do not work with two companies who compete in the same market. Our goal is to develop life-long relationships with senior leadership teams who are deeply aligned with our own values and will confidently refer our services.

As a Certified B Corp we have committed to meeting comprehensive and transparent social and environmental performance, meeting higher legal accountability standards. We consider all of our stakeholders including employees, suppliers, customers, shareholders, the community and the environment when making business decisions. We encourage you to learn more about B Corps at (http://www.bcorporation.net/ianmartingroup).

We are a different kind of retained search firm and connect leaders who believe, as we do, that good stewardship and social responsibility are just good business.


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