Compliance Co-ordinator

Job Overview

To assist in the day to day running of the Norbrook production facility and help improve output and efficiencies.

Main Activities/Tasks

• Review and record relevant production KPls .
• Processing and reviewing PCRs and SPRS on site in a timely manner.
• Ensure all records such as cleaning records, logbooks and calibration records are maintained by operatives.
• SOP Custodian for site.
• Ensure training of staff on most recent versions of SOPs is carried out.
• Responsible Employee, issuing Working Copy stamped documentation on site e.g. appendices, generating logbooks etc.
• Request and review PCR's, SPRS and relevant appendices.

Safety

• Understand and follow the company's Health & Safety policies .
• Ensure a 'safe culture' and an appreciation of the materials, processes and systems is embedded within the organisation.
• Act as point of contact for external contractors and fill out work orders on site.

Operational

• Provide timely, detailed and accurate reports on the status of manufacturing and packing operations, alerting the senior management of any issues which may impact on finished product quantities and availabilities.
• Liaise with other departments such as Engineering, Process Excellence, Validations and Quality to ensure all production equipment and areas are fully compliant with all GMP and customer requirements.
• Assume responsibility for assigned Operational and Compliance metrics.
• Undertake any other duties, which may be assigned by Senior Management.

Quality

• Comply with all aspects of the Norbrook Quality System.
• Ensure that a 'quality culture' and an appreciation of the quality system is embedded within the organisation.
• Adhere to the principles of Good Manufacturing Practice ensuring product is manufactured within the defined parameters of the Quality Management System.
• Where deviations occur suggest and implement CAPAs.
• Participate in investigations and suggest CAPAs for manufacturing issues.
• Ensure all documentation (e.g. production control records, log books, training records etc) are completed in line with good manufacturing practices and expectations.
• Ensure all assigned quality events (e.g. deviations, complaints, CAPAs, change controls etc) are addressed in a timely manner.
• Identify true root cause in all quality related investigations to prevent reoccurrence and improve compliance, product quality and safety.
• Reporting through the QA Department, you will have the responsibility to approve and control the issuing of Working Copy Documents for the recording of data within the GMP environment

Corporate

• Work towards the company mission, strategy and culture

Essential Criteria:

• A level qualification in English and Maths (or a closely related area) •
• Able to demonstrate ability to motivate and train team members.
• Ability to prioritise and meet targets.
• Excellent communication skills both verbal and written
• Proficient in all Microsoft packages

Duration: Full time, Permanent

Location: Newry

Additional Information:

• Applicants should be able to provide proof that they have a right to work in the Ireland at the time of their application. Applicants who are unable to provide this proof will not be considered.
• We regret that applications received after the closing date and time will not be accepted.
• We are unable to sponsor or take over sponsorship of a Visa at this time.