QA Specialist

Found in: beBee S IE - 1 month ago

Dublin, Ireland Cpl Remote Work Freelance Full time

Cpl in partnership with SK biotek are hiring for QA Specialist (Operations) to join the team on a 12month contract in Swords Campus.


The QA Specialist is primarily responsible for batch record review, disposition and batch release activities. These activities take place on-site. The QA specialist is further responsible for supporting daily on-site Operations (Manufacturing, Utilities, Facilities, Engineering, Warehouse etc.) and for the execution of key quality activities and programmes of supplier management, process validation, cleaning validation, stability management and maintaining quality systems.

Responsibilities:

Manage Operations or Operational Duties

â¢Â Â Â Â Â Â Â Â Â Â Â Perform material set up for new product introduction.

â¢Â Â Â Â Â Â Â Â Â Â Â Support quality activities associated with approval and management of material vendors and GMP service providers.

â¢Â Â Â Â Â Â Â Â Â Â Â Review purchase specifications.

â¢Â Â Â Â Â Â Â Â Â Â Â Support the TSE/BSE program.

â¢Â Â Â Â Â Â Â Â Â Â Â Review and approval of manufacturing and cleaning batch documentation in accordance with cGMP.

â¢Â Â Â Â Â Â Â Â Â Â Â Final disposition of material.

â¢Â Â Â Â Â Â Â Â Â Â Â Generation of electronic and manual certificates of analysis and certificates of conformance as required.

â¢Â Â Â Â Â Â Â Â Â Â Â Perform pre-operational inspections as required for the plants, maintenance, warehouse and technical services.

â¢Â Â Â Â Â Â Â Â Â Â Â Ensure effective shop floor presence through real-time monitoring and trending of routine and pre-operational checks/ audit observations. Coordination of trend data on a monthly basis.

â¢Â Â Â Â Â Â Â Â Â Â Â Preparation, review and approval of GMP SOPs, where required.

â¢Â Â Â Â Â Â Â Â Â Â Â Preparation of Process and Cleaning validation protocols and reports. Review of change controls

â¢Â Â Â Â Â Â Â Â Â Â Â Review and approval of master batch records.

â¢Â Â Â Â Â Â Â Â Â Â Â Prepare QA sections of Process Verification Reports.

â¢Â Â Â Â Â Â Â Â Â Â Â Prepare Annual Product Reviews (APR) in line with the APR schedule.

â¢Â Â Â Â Â Â Â Â Â Â Â Prepare stability reports, including trending for APRs.

â¢Â Â Â Â Â Â Â Â Â Â Â Participate in the site investigation process supporting the identification of root cause and appropriate corrective actions.

â¢Â Â Â Â Â Â Â Â Â Â Â Investigate low-risk deviations as required.



Validation

â¢Â Â Â Â Â Â Â Â Â Â Â Review and approval of validation protocols and reports for facilities, equipment, laboratory and control system validation.

Customer support

â¢Â Â Â Â Â Â Â Â Â Â Â Support quality related customer requests and queries.

â¢Â Â Â Â Â Â Â Â Â Â Â Comply with the requirements in the relevant quality agreements.

Manage and Communicate Information/Provide Data

â¢Â Â Â Â Â Â Â Â Â Â Â Delivery of induction and quality-related GMP training for all personnel on-site.

â¢Â Â Â Â Â Â Â Â Â Â Â Preparation and update of training documents, courses and assessments.

â¢Â Â Â Â Â Â Â Â Â Â Â Compile site quality metrics on a weekly, monthly and quarterly basis as required for tier meetings and quality council. Use critical analysis and scientific reasoning to resolve issues.

Interactions with People

â¢Â Â Â Â Â Â Â Â Â Â Â Represent QA Department on site.

â¢Â Â Â Â Â Â Â Â Â Â Â Improving standards of GMP on-site through shop floor presence and new initiatives.

â¢Â Â Â Â Â Â Â Â Â Â Â Work within a team environment to support QA Department in its role to achieve compliance in all aspects of the site activities.

â¢Â Â Â Â Â Â Â Â Â Â Â Participate in regular department team meetings.

â¢Â Â Â Â Â Â Â Â Â Â Â Liaise with all change control originators to ensure that changes are auctioned and closed in a timely manner.

Safety

â¢Â Â Â Â Â Â Â Â Â Â Â Ensure that a culture of safety is implemented in QA by participating in safety meetings and safety initiatives.

â¢Â Â Â Â Â Â Â Â Â Â Â Ensure all site rules and procedures governing safety, environmental protection, quality and personal conduct are complied with by oneself, colleagues and visiting contractors.


Required Competencies             

Essential

â¢Â Â Â Â Â Â Â Â Â Â Â Good time management and organisational skills.

â¢Â Â Â Â Â Â Â Â Â Â Â Ability to multi-task numerous projects.

â¢Â Â Â Â Â Â Â Â Â Â Â Ability to work with initiative.

â¢Â Â Â Â Â Â Â Â Â Â Â Good interpersonal skills.

â¢Â Â Â Â Â Â Â Â Â Â Â Good communication and presentation skills; confident public speaker.

â¢Â Â Â Â Â Â Â Â Â Â Â Ability to identify and challenge areas to ensure implementation of lean QA initiatives.

â¢Â Â Â Â Â Â Â Â Â Â Â Good coordination capabilities.

Desirable

â¢Â Â Â Â Â Â Â Â Â Â Â Flexible and motivated

â¢Â Â Â Â Â Â Â Â Â Â Â Ability to achieve targets and milestones

 

Required Qualification(s) and Desired Experience          

â¢Â Â Â Â Â Â Â Â Â Â Â Min of BSc /BEng in chemistry, engineering or science-related discipline with at least 1 year of pharmaceutical experience, ideally in a QA role.

â¢Â Â Â Â Â Â Â Â Â Â Â Knowledge of the principles of validation and qualification.

Values 

The qualified candidate demonstrates characteristics of SK biotek Ireland values.

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