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Specialist, Quality Assurance
Posted on 27 February 2020
Theratechnologies Inc. is looking for a Quality Assurance (QA) Specialist to support the Manager of Quality Assurance in order to ensure the consistency of the quality standards and to approve or reject the release of finished drug batches, in relation with the quality standards as per the Good Manufacturing Practice (GMP). The QA Specialist will also support the Director of Regulatory Affairs, Quality and Compliance in compliance-related tasks.
Support in the following QA activities
- Creates 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.
- Qualifies service providers: inspects their facilities; identifies and recommends corrective and preventive actions.
- Negotiates quality agreements with the various external partners.
- Evaluates the end-products’ quality and determines whether to withhold the batches or release them for distribution.
- 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 and preventive actions.
- Evaluates the investigations and provides corrective and preventive actions.
- Facilitates the conduct of audits and performs internal and external audits.
- Contributes in the budget preparation for quality-related activities and ensures proper follow-up.
Support in the compliance-related activities
- Ensures the maintenance of the policies and procedures of the pharmaceutical compliance program regulations in order to avoid conduct that might lead to potential violations.
- Collaborates with the different departments if a compliance issue arises in order to determine the appropriate actions for issue resolution.
- Analyzes the complaints or queries related to rules, policies, procedures and codes of conduct, and proposes the necessary solutions.
- Facilitates the circulation of compliance-related information to all the company’s stakeholders.
- Ensures that the policies and procedures are drafted and reviewed to ensure conformance with the applicable standards.
- Reviews any document, package and label to ensure proper conformance.
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 products.
Documentation, procedures and systems
- Reviews and approves the documents, specifications, procedures, labels, packaging products, manufacturing and packaging master batch records, protocols, validation reports, and deviations.
- Verifies temperature data during the transportation of the products and determines their status/disposition.
- Determines the disposition of a nonconforming product and proposes the necessary solutions.
- Establishes and maintains a change control system.
- Reviews the production documentation and the investigations for customers’ complaints related to product manufacturing and packaging.
- Analyzes statistical data on complaints and deviations and recommends actions.
- Drafts procedures, specifications, explanations, appropriate corrective and preventive actions, and change requests.
- Reviews and approves the annual quality review of the products.
- Produces forms, memos, lists and reports for required documentation.
- Performs any other task as requested by management/direct supervisor.
- Quality team of external partners.
- Quality suppliers/vendors.
- Bachelor’s degree in Pharmacy, Chemistry, Biology or Chemical Engineering.
- Quality assurance training.
- 3-5 years of quality assurance experience in the pharmaceutical industry, ideally with sterile products, pharmaceutical a/o biological products.
- Experience in Oncology or in any other therapeutic field is an asset.
- Good understanding or experience in laboratory research, pre-clinical and/or clinical research is an asset.
- Experience in performing or contributing in quality/GMP audits.
- Experience in policies and procedures related to the pharmaceutical GMP compliance program and regulations.
- Proficiency in quality assurance terminology.
- Good 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 for all Staff
- Ability to set goals and objectives and meet deadlines.
- Ability to prioritize.
- Ability to generate ideas and find solutions.
- Ability to work independently and in a team environment.
- Team spirit and willingness to assist team members
- Versatility and flexibility.
Personal Qualities Specific to the Position
- Leadership and accountability.
- Result oriented.
- Ability to negotiate and influence others.
- 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.