Full-Time Compliance Coordinator
Job Description
Position: Compliance Coordinator Posting No:
Reports to: Quality Assurance Supervisor Posting Date:
Closing Date:
Overall Responsibilities
The Compliance Coordinator will perform quality audits and in-process inspection on the manufacturing operations, packaging operations, and warehousing operations within the facility thus ensuring that quality manufacturing as defined by GMP is maintained. In addition, the Compliance Coordinator will assist the Quality Assurance Supervisor in supporting systems to ensure quality manufacturing as defined by Good Manufacturing Practices (GMP) relating to natural health and pharmaceutical products. Ensure appropriate compliance to all relevant regulatory requirements.
Specific Key Responsibilities & Duties
- Act as the qualified person (as defined under section 51 of Good Manufacturing Practices Guidelines) in the disposition of finished product.
- Responsible for investigating quality related deviations and incidents
- Participate in SOP management
- Participate in Change Control approval process
- Responsible for conducting Internal Audits
- Responsible for investigation Consumer Complaints.
- Responsible for the annual review / trend reports (Critical Deviations, Rejection, etc.)
- Participate in CAPA investigations and write investigation reports
- Report and respond to quality process deviations in an expedient manner
- Provide assistance for other departments concerning quality related issues
- Prepares compliance audit data by compiling and analyzing internal and external information.
- Supports departments by collecting and coordinating internal compliance data with auditors and various departments.
- Participate in approval process of raw material vendors, component vendors and sub-contractors.
- Troubleshoot non-compliance issues as they relate to sub-contracted products.
- Responsible for the audit schedules, review of audit reports and follow-up
- Provide assistance to sub-contractors in developing quality related systems.
- Assist with QA operations in Deacom ERP system including BOM review, user field population, uploading documents, inputting lab results when needed.
- Working in compliance with the company’ s Health & Safety Policies/SOP’s including but not limited to the Safety Responsibilities Procedure.
- Responsible for the governance of GMP documents
- Will comply with Good Manufacturing Practices in all GMP sensitive areas of the facility
- Perform other related duties and projects as assigned
Qualifications and Behavioural Requirements:
- Bachelor’s degree or college diploma in chemistry, biology or related scientific discipline.
- Quality Assurance Certificate, HACCP, or Food Safety Certificate, and/ or minimum 1 year industry experience.
- Knowledge and understanding of GMP and Health Canada Regulations for natural health products and food.
- Good knowledge and understanding of quality and testing requirements and US Pharmacopoeia.
- Flexible hours and weekend work maybe required.
- Knowledge of testing limits for raw materials and finished products.
- Good understanding of data analysis and report preparation with solid knowledge of MS Word, Excel, and Outlook.
- Knowledge of ERP software
- Effective analytical problem solving and organizational skills.
- Detail-oriented and excellent written and oral communication skills.
- Ability to work with minimal supervision.
- Excellent interpersonal skills with the ability to work in a team environment.
- Ability to handle strict deadlines and work under pressure.
Our Values
TEAMWORK – We collaborate towards common goals and objectives; We celebrate wins and learn from losses together; We appreciate and value each other’s contributions; We ensure our team goals trump individual or departmental interests;
ENTREPRENEURSHIP – We foster creative, innovative and empowered thinking at all levels; We are agile and Responsive to changes; We are consumer obsessed and data based; We demonstrate initiative and take calculated risks;
ACHIEVING RESULTS – We achieve stretch goals; We objectively use data to measure progress; We lead with a passion for winning; We demonstrate a bias for action; We show a consistent commitment to excellence and expect it from others;
INTEGRITY – We do what we say; We do what is right even when it’s not easy; We demonstrate mutual respect and inspire trust; We seek and accept accountability; We take a quality approach in everything we do;
TRANSPARENCY – We communicate openly, honestly and directly; We encourage productive and respectful conflict to develop the best solutions; We provide and share information to enable sound decision making at all levels;
EXTERNAL FOCUS – We continually seek understanding of forces that affect our business, customers, consumers, government, technology, competition and suppliers; We proactively solicit the views of the outside world on how we’re doing and what to improve; We foster relations with outside influencers to gain proactive insight in the latest developments that could affect our business; We review and discuss necessary change regularly to incorporate it into our strategy.
How to Apply
HOW TO APPLY: All those interested in applying for this job posting may do so by submitting an application to the Human Resources Department by the closing date noted above. Previous work history will be considered in the final selection. We are an Equal Opportunity Employer and welcomes and encourages applications from all interested and qualified candidates. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code, the Company will provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities. If selected to participate in the recruitment, selection and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.103 total views, 0 today