Quality Assurance Specialist

PUB289947

About this role

We’re hiring a Quality Assurance Specialist to work with our client, a biopharmaceutical company in Montreal, QC. This is a permanent role;

The incumbent supports the Associate Director, Quality Assurance (QA) in order to ensure the consistency of the quality standards as per the Good Manufacturing Practices (GMP) during the documentation review, including but not limited to the quality agreements, products’ annual reviews, specifications, change control, complaints, audits, CAPAs, SOPs, etc.; to approve or reject the release of Active Pharmaceutical Ingredients (APIs) or end-product batches. The incumbent will also support the Director of Regulatory Affairs, Quality and Compliance in compliance-related tasks.

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.

Requirements

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.

Benefits

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Start applying immediately

Sending an application is quick and easy. Just make sure you have the required documents ready to go.

  • Certifications (optional)
  • Job references (optional)
  • Motivation Letter (optional)
  • Resume or up-to-date LinkedIn / Xing profile
Apply now

Any questions remaining?

Your consultant, Monnatha Grego is happy to clarify anything about this vacancy. When reaching out, use the pub number:
PUB289947

Account manager

Monnatha Grego
Brunel Canada - Calgary
m.grego@brunel.net

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