QA Specialist

Job Purpose:

To confirm that API and intermediates have been manufactured and tested in accordance with registered details, Product Requirement Specifications and in accordance with relevant GMP and client quality agreements.

To support introduction and manufacture of new clinical and commercial products to site.

To provide assistance and guidance on QA related issues both within Quality team and to other teams on site. 

Skills Required:

• Good Interpersonal skills and ability to interact with people
• Be flexible and adjust to business needs in a fast CDMO environment
• Good Facilitation and presentation skills
• Good organizational skills
• Positive, can-do approach and enthusiasm
• Innovative, with the potential for scientific leadership
• A good team player, able to work confidently in teams in a multi-disciplinary environment and communicate with customers
• A demonstrated commitment to Quality, EHS and Continuous Improvement

Areas of Responsibility:

• Carry out routine QA review of process manufacturing batch records for completion and accuracy.
• Report any non-compliances and participate in subsequent investigation.
• Approve manufacturing batch records
• Co-ordinate deviation notifications and ensure that these are closed out within 30 days or as per relevant Client Quality agreements. Ensure appropriate investigations are performed on all deviations
• Review and approve any minor change controls or in process changes associated with Manufacturing Batch Records and Processes.
• Carry out routine QA review of cleaning batch records for completion and accuracy.
• Review and approve all the relevant cleaning documentation from a QA perspective (pre-approval and post-approval
• Carry out API batch approval
• Issue/approve COA’s in compliance with customer requirements for each batch exported from site. 
• Where appropriate assist in the investigation/reporting of customer complaints.
• Obtain a working knowledge of all relevant site and analytical Standard Operating Procedures and, where assigned, participate in the preparation/revision of QA SOP’s.
• Maintain individual training records on an ongoing basis. Participate in the training of team members as appropriate.
• Support or participate in GMP Audits as required
• Maintenance of other QA compliance activities such as PM notifications, packaging specifications, etc.
• Participate in the site POD teams (includes operations, PDS, MSAT and engineering) to ensure
• Work closely with STLs and Shift Managers to support relevant Culture and Quality improvement initiatives
• Be aware of current and emerging GMP standards and provide an informed QA opinion to other teams. 
• Lead/participate in site GMP initiatives as required
• Be up to date with current Quality guidelines e.g. ICH, GQMP, FDA, HPRA
• Apply continuous improvement to the Quality processes using PPI tools and look continuously for process simplification opportunities while maintaining compliance with the regulatory requirements.