Validation Coordinator

General information

Reference

2023-1527

Position description

Job Title

Validation Coordinator

Company Details

Novocol Pharma is a growing contract development and manufacturing organization (CDMO), specialized in sterile injectable cartridge and combination product manufacturing. We strive for excellence and customer-centricity to deliver value to global pharmaceutical clients through contract services for drug development and commercial manufacturing. With over 40 years in operation, our team of 600 employees and modern facilities, located in Cambridge, Ontario provide a personalized and responsive experience for our customers. We are focused on serving our strategic partners and patients with quality, integrity, and value.

Our employees are our number one asset! We offer developmental opportunities, excellent compensation and benefit programs, discounted gym memberships, work/life balance programs, employee recognition, social events and spirit days.

We are a proud member of the Septodont group of companies. Septodont is a pharmaceutical and medical device company with a global leadership position in dental pain management. The group counts over 2000+ employees worldwide and has remained a 100% family owned company for over 90 years. Our Cambridge facility serves as a significant manufacturing site within the Septodont group with high volume dental anesthetic production for a global customer base.

We have an opportunity for a Validation Coordinator.

Job Summary

The Validation Coordinator position is accountable to the Validation Manager and is responsible for the execution of technical writing (creation and revision), training coordination, investigations special projects and continuous improvement initiatives within the Validation Department.

Responsibilities

Creates, revises, and manages technical and quality documents for the department such as protocols, reports, SOPs, logbooks, and batch records both in paper and in electronic formats.

Acts as main point of contact for the department to rollout key sitewide program initiatives, drive continuous improvement initiatives and standards.

Coordinates and facilitates investigations for department; represents department for cross functional investigations and brings investigations to completion for safety and quality events for the department, including AIRs, DIRs, DCR, TCR, CAPA.

Provides project support including assisting in scheduling, preparation and execution activities for department including documentation deliverables.

Collects data and prepares reports for various projects and initiatives.

Prepares training packages, training documentation and schedules training sessions.

Organizes meetings, conference calls, video conferences and take minutes as required.

Provides memos, reports, Power Point presentations, letters, agendas, itineraries, and any other such confidential materials and/or administrative support as required.

Provides assistance on a wide range of organizational, departmental projects, and other duties as assigned.

Other related duties as assigned.

Follow GMP and regulatory requirements, and ensure quality standards are met.

Observe and support all safety guidelines and regulations.

Demonstrate the Company Mission, Vision and Values Statement, policies, and current standard business practices.

Qualifications

Education

University degree in a science-related discipline.

Experience

2 years of related experience is an asset.

Acute attention to detail.

Well-developed time management skills and effective technical writing skills.

Ability to work in a self-directed team environment.

Familiarity with Microsoft Office applications, especially Excel, Word and Power Point.

What we offer

Excellent compensation/benefits package.

Bonus and reward programs

Discounted gym memberships

Programs supporting work life balance

Employee recognition program

Professional and personal development programs

Social events and spirit days

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.

Internal Job Posting Level 8. The due date for internal applicants to apply for this role is 18-Sept-23.

Contract type

Permanent

Candidate criteria

Minimum level of education required

3- Bachelor

Minimum level of experience required

Less than 2 years

Position location

Job location

North America, Canada, Cambridge