Job Description

Job Description

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 development

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

Position Title : Pharmaceutical QA Associate and Data Reviewer (Full-time)

Reports To: Head of Quality & Compliance

Job Description:

The QA Associate and 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 and skills to ensure the Quality and Compliance department performance and service meets the highest quality, regulatory and industry standards.

As a Senior Quality and Compliance Specialist 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 and 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.
• Leading 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.

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 hands-on experience working in pharmaceutical QA environment..
• Sound knowledge of pharmaceutical analytical method development, method validation, investigational studies, method transfer, stability studies and preparation/execution of 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.
• Be able to conduct laboratory investigation and other quality attributes (e.g. SOP development, Change Control, Deviation, Root Cause investigation and analysis, CAPA, etc.).
• 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)

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. Kindly refrain from applying if you are not qualified.

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

No phone calls please.

Job Tags

Similar Jobs