Job description

About Shields Pharma Inc.

Shields Pharma Inc. is a Health Canada approved GMP organization located in Markam, Ontario

We offer Laboratory R&D and QC testing services as well as production and formulation of psychedelic therapeutics for treatment of certain mental health disorders such as anxiety, depression, obsessive-compulsive disorder, PTSD, and problematic substance abuse..

Shields Pharma Inc. is an equal opportunity employer committed to diversity and inclusion for everyone. We are continuously looking for smart-minded, skilled, qualified, experienced, independent, reliable and detail-oriented candidates to join our successful team.

Our people are at the heart of everything we do.

You can count on;

• Safety as our first core value
• Integrity
• Accountability
• Continuous training and skill developmen

We are currently looking for a Senior Quality & Compliance Specialist to join our growing team!

Position Title: Pharmaceutical QA Associate and Analytical Data Reviewer 

Reports To: Head of Quality & Compliance

Job Description:

Pharmaceutical Analytical Data Reviewer is a technical expert in our QA department operation, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department.

You will use your expertise to ensure the Quality and Compliance department’s performance, and service meets the highest quality, regulatory and industry standards.

As an Analytical Data Reviewer, you should have a sound knowledge of pharmaceutical cGMP, GxPs, GDP, ICH, FDA CFR 211, ALCOLA+, etc. guidelines and regulations.

This position relies heavily on a comprehensive understanding of laboratory operations, analytical methods and instrumentation including general wet chemistry and instrumentation such as LC/MS/MS, HPLC, GC-Headspace, GC/MS, ICP-MS and Dissolution.

We are seeking a motivated individual with a pharmaceutical quality assurance background to play a critical role and provide quality oversight on processing of all internal & external GxP documentation. This position reports to the Head of Quality & Compliance department

Duties shall include, but are not limited, to the following

• Ensuring the company processes, procedures and policies are complying with current Health Canada, US FDA, WHO, and European Good Manufacturing Practices (GMPs), GxPs, ICH, MHRA, ALCOLA+ guidelines and regulations.
• Performing Quality Control (QC) and R&D technical, scientific, and compliance review of data, reports, protocols, analytical results, and any other documentation generated by the laboratory including lab reports, records of procedures, results and data analysis.
• Identifying deviations, OOS and OOT associated with analytical testing data as applicable.
• Issuing QC review observations and working closely with the scientific staff to ensure data integrity.
• Collecting metrics data used to monitor the QC reviews, and may identify process improvements
• Assist in educating, guiding and influencing the laboratory staff in regard to best practices in GxP compliance.
• Developing GMP documentation such as SOPs, forms, protocols, reports, etc.
• Demonstrating sound knowledge of the operation of analytical and quality control activities.
• Ensuring all data and documentation generated by the laboratory are accurate and in accordance with Good Documentation Practices (GDP) guidelines.
• Coordinating laboratory investigations from initiation to closure of investigation.
• Preparing and approving analytical test results CoAs.
• Leading, conducting and/or participating in deviations, laboratory OOS and OOT investigations, managing change controls, CAPA and customer complaints
• Managing and delivering company’s training program.
• Coordinating and participating in Shields Pharma Inc. inspection programs including; internal audits, client and supplier audits and regulatory inspections.
• Providing inspection readiness support including front room and backroom activities.
• Working with cross functional stakeholders to ensure follow-up of quality issues as requested.
• Ensuring equipment/instrument qualifications, calibrations, repairs and maintenance documentations are reviewed, up-to-date, and archived.
• Keeping all quality and laboratory reports, records, and analyst note-books in good order.
• Preparing comprehensive and accurate Analytical CoAs and Reports in timely manner

Job Requirements: (Work Status, Qualification, Knowledge, and Experience)

• Must possess Permanent Canadian residency with work permit and/or Canadian citizenship.
• Must be living in Canada, preferably in Toronto area
• Minimum B.Sc. degree in Chemistry, Pharmaceutical, Analytical Chemistry or similar applied scientific disciplines.
• Minimum of 3 years of direct and direct experience working as laboratory data reviewer pharmaceutical QA environment..
• Sound knowledge of pharmaceutical analytical laboratory analytical methods and instrumentation.
• Proficiency in method development, method validation, investigational studies, method transfer, stability studies and preparation/execution of reports and protocols, etc.
• Well versed in understanding of USP, BP, EP, and JP methods and specifications.
• In-depth knowledge and competency in cGMP/GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GXP, FDA CFR 211, ICH, and ALCOLA+ regulation and quality system guidelines.
• Experienced in creating, and reviewing SOPs, OOS, Change Control, etc. reports
• Track record of multi-tasking, being detail-oriented, trouble-shooting/problem solving abilities, working with minimal instruction on routine work and moderate instruction on new assignments.
• Strong problem-solving skills, with sound judgment and the ability to make decisions independently while balancing business needs, quality and compliance risks.
• Strong organizational skills and the ability to manage multiple tasks and responsibilities in a dynamic work environment
• Be able to work in a fast-paced environment with significant responsibilities and follow assignments through to completion to meet agreed timelines.
• Be a team player, punctual and have strong communication skills.
• Proficiency with MS office (Excel, Word, PowerPoint)

How To Apply:

Please reference “QA Analytical Data Reviewer” in subject line and submit resume with cover letter to hr@shieldspharma.com

The information collected to review your application will be processed by the human resources services
We welcome and encourage applications from all qualified applicants. We are committed to adhering to our company objectives and requirements outlined above.

We thank all applicants for their interest, however, only those qualified and selected shall be contacted for an interview.