Quality Assurance Specialist

About this role

Responsibilities

Support in the QA activities;

• Reviews acceptance specifications and criteria;
• Ensures that the products’ manufacturing, packaging and analysis are defined, controlled and in conformity with the GMP;
• Reviews the stability data and approves the new testing or expiry date;
• Negotiates quality agreements with the various external partners;
• Evaluates the APIs and end-products’ quality and determines whether to withhold the batches or release them;
• Ensures that all manufacturing steps are followed and in conformity with the GMP;
• Participates in the complaints’ evaluation in order to identify the causes and recommends corrective/preventive actions;
• Evaluates the incidents and provides corrective/preventive actions;
• Participates as QA expert to the regulatory audits;
• Reviews/evaluates change control;
• Ensure timely completion of deviations, complaints, CAPAs, change control, etc. as per the established procedures;
• Contributes to the maintenance of the Quality System and the KPI’s report;
• Escalates any deviation to the GMP, complaints or risk assessment that may impact the patients’ security or the product’s quality, integrity or purity;

Support in the compliance-related activities;

• Ensures that policies and procedures are written and revised to ensure their conformity with the standards;
• Reviews all documents, packages and labels to ensure proper conformity;
• Conducts internal audits to ensure the conformity with internal procedures and GMP rules;
• Supports regulatory audits;

Key resource person for Quality Assurance Matters;

• Acts as the representative of the quality and compliance team in the various committees and work groups;
• Evaluates and ensures the disposal of returned product.

About you

Requirements

• Bachelor’s degree in Pharmacy, Chemistry, Biology or Chemical Engineering;
• Quality assurance background;
• 5 - 8 years of quality assurance experience in the pharmaceutical industry, ideally with sterile products, pharmaceutical a/o biological products;
• Good understanding or experience in laboratory research, pre-clinical and/or clinical research is an asset;
• Experience in policies and procedures related to the pharmaceutical compliance program;
• Excellent knowledge of the GMP, GLP, GDP, as well as the pharmaceutical industry’s;
• guidelines and regulations;
• Knowledge of Word, Excel, PowerPoint and Outlook;
• Previous experience working with databases;
• Bilingual French and English, spoken and written;

Personal Qualities Specific to the Position;

• Leadership and accountability;
• Result-oriented;
• Ability to negotiate and influence others;
• Multitasking;
• Analytical capabilities and ability to synthesize information;
• Planning and organizational skills;
• Good stress management;
• Attention to detail and quality;
• Verbal and written proficiency;
• Thoroughness in accomplishing tasks;
• Available for occasional business travels.

What we offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We’ll get you going while you get on with the job.