Science & Pharmaceutical JobsQuality Operations Specialist

  • CJ50925
  • Permanent
  • Waterford

Collins McNicholas

JOB Title: Quality Operations Specialist 

 

Job Responsibilities:

–         To effectively manage and report all Quality Metrics within the Biopharmaceutical Chemistry team including Exceptions, CAPA’s, Change controls, SOP’s. Ensuring all actions are assigned and tracked to ensure compliance  with company metrics

–         Completion of Biopharmaceutical Chemistry approval of Quality documentation e.g. Exceptions, CAPA’s, SOP’s, Quality and technical agreements.

–         Lead cross-functional risk assessment as required within the team

–         Assist in problem-solving within the department.

–         To ensure processes and systems are in place to ensure that Quality/ CAPA related project work is completed as required and associated customer reports are available in a timely manner.

–         To provide continuous feedback to all members of the team on all items in relation to customer or Quality requirements/changes.

–         To handle assigned customer related query and lead the investigation of any complaint, liaising with their team to problem solve these queries if needed.

–         To support internal and External/regulatory audits for area of responsibility, including audit preparation, queries during the audit and follow up of actions to closure. Finalising CAPA’s and associated deadlines.

–         To represent Biopharmaceutical Chemistry in the Change control Review board as required.

–         To approve and keep updated laboratory SOPs in their area of work.

–         To identify any opportunities for improvement of quality and customer service and support the team to implement continuous improvement initiatives/projects.

–         To establish and manage key metrics in the areas of quality, customer satisfaction/delivery. Ensuring specific targets are set, met and any trends noticed are addressed. 

–         To ensure the quality of the day-to-day work of the team continues to meet company standards and for problem solving any quality issues with other members of the organisation.

–         To ensure all related documentation is completed and filed accurately, updated as required and on time in line with company procedures.

–         Provide coaching and mentoring to the team as required to improve understanding and compliance in all areas of Quality.

–         Responsible for reviewing data to the relevant regulatory standard, analytical procedures and appropriate documentation.

–         Responsible for the review of specific technological projects and writing up the results of these projects accurately, confidentially and on time for the clients.

–         To continually liaise with management, customers and other members of the organisation on any relevant problem areas or enhancements to the business.

–         To adhere to all company standards in the area of safety, housekeeping and quality, notifying management of any discrepancies.

 

QUALIFICATIONS

–         A Degree in science.

 

Experience / Skills

–         5 years’ experience in a regulated GMP laboratory environment. 

–        Good team player, organised, accurate, have strong documentation skills.

–         Passionate about quality and customer service.

–         Good communication skills both internally and externally. Ability to understand customers’ requirements and to be able to devise and articulate the most appropriate solutions.

 

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