Quality Assurance Associate

at  Bimeda

OTHER REQUIREMENTS:

Essential:

• BSc degree in science or related field,
• knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry
• High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative

Desirable:

• 2-3 years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control
• QA courses or training

PURPOSE OF THE POSITION/ ROLE SUMMARY:

Reporting to the Quality Assurance Supervisor, the Quality Assurance Associate is directly involved in ensuring that the production & distribution of products meets quality standards by performing detailed review of technical documents, monitoring and trending production data, assessing impact of change requests, verifying product quality, resolving deviations, and ensuring timely approval and release of products as per GMP standards. In addition, the QA Associate will participate in handling customer complaints and product inquiries. The role includes coaching/training operators and supervisors on proper documentation practices on cGMP requirements. This position is a full-time, on-site role.

KEY ROLE SPECIFIC REQUIREMENTS:

• Assesses potential impact of incidents and 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.
• Performs internal QA audits on manufacturing lines and finished products to ensure that they are compliant with corporate policies, practices, and procedures. Creates and maintains QA control documentation.
• Provides 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.
• Investigates both individually and as a team member, product complaints, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
• Monitors QA systems and advises/presents to management team on system performance; publishing metrics/reports regarding performance against set goals.
• Maintains the QA program for monitoring supplier quality, including conducting audits, establishing controls, and checking other qualifiers.
• Conducts annual product reviews by reviewing all production documentation and summarizing key issues and providing final reports on the quality of the product manufactured.
• Responsible to ensure that all customer complaints are investigated and reported in a timely manner as detailed in applicable SOP’s and regulations. Includes collaborating with client-facing QA representatives on an on-going basis to ensure full customer satisfaction with the company’s products and services.
• Provides 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.
• Promotes and advocates quality achievement and performance improvement across the organization.
• Participates as required in Health Canada, FDA & customer audits and ensures corrective actions are completed with customer specifications or SOPs.
• Ensures ongoing compliance with local, national, and international standards and legislation.
  Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

COMPETENCIES REQUIRED FOR THE ROLE:

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 effect from this
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 whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
FLEXIBILITY/OPENMINDEDNESS -The ability to be open to different and new ways of doing things; willingness to modify one’s preferred way of doing things. Is able to see the merits of perspectives of others than his/her own
INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled