QA Associate - Cambridge, Canada - Bimeda

Bimeda

Verified Company

Cambridge, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Reporting to the QA Supervisor, the QA Associate will work within an established culture of Quality Assurance and continuous improvement in all GMP areas.

The QA Associate will be directly involved in all areas of quality assurance, including change control, Annual Product Reviews (APRs), product release, review of technical documents, deviation resolution and ensuring GMP standards are met.

In addition, the QA Associate will participate in handling customer complaints and inquiries of the products. The role includes coaching/training operators and supervisors on proper documentation practices and on cGMP requirements.
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Job Requirements_

Conducting annual product reviews by reviewing all production documentation and summarizing key issues and preparing final reports on the quality of the product manufactured.
Assessing potential impact of incidents and processing deviations on the quality and suitability of the product for sale. Includes conducting batch record review and determining batch status, e.g. release, reject or product hold for further clarification or investigation.
Providing oversight and QA approval to various systems (CAPA, Deviation, Change Requests) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed.
Investigating both individually and as a team member, product complaints, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
Monitoring QA systems and advising/presenting to executive team on system performance; publishing metrics/reports regarding performance against set goals.
Lead change control initiatives and facilitate documentation updates utilizing Microsoft Word and ZenQMS software.
Performing internal QA audits that are compliant with corporate policies, practices, and procedures.
Collaborating with clientfacing QA representatives to ensure full customer satisfaction with the company's products and services;
Providing support to other functions of Quality Assurance department which includes but not limited to the preparation of master documents and the coordination of documentation services through other departments.
Promoting and advocating quality achievement and performance improvement across the organization.
Ensuring ongoing compliance with local, national, and international standards and legislation.
Participating in Health Canada, FDA & customer audits and ensuring corrective actions are completed as required.
Creating and maintaining QA control documentation.
Other job duties as required.

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Other Requirements_

University degree in a related Science along with specific Quality Assurance education or training;
Minimum 2 years of direct work experience with pharmaceutical QA systems, regulations, guidelines, and associated standards;
Direct knowledge of pharmaceutical QA methodologies;
Training and knowledge of cGMP regulations;
Extremely detailoriented and analytical thinker with strong problemsolving ability;
Able to develop, review, and maintain metrics and quality audits;
Able to interface directly with crossfunctional teams;
High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative

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Competencies Required for the Role_

FOSTERING COLLABORATION/TEAMWORK:

- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen - help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

EXECUTION/ACCOUNTABILITY - A willingness to accept responsibility or to account for one's actions. Accountability is when an individual or a department experiences consequences for their performance or actions.

ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and