The Quality Manager has overall responsibility for the design and functioning of the Quality Management System and must ensure that it complies with the facility’s Manufacturing and Importation Authorisations and regulatory requirements. Some responsibilities of the QM may be designated to the Quality Associates as defined in specific Standard Operating Procedures.
Reports to: Chief Executive Officer
Direct Reports: Quality Assurance Associates/QC inspector
Ensure the company’s Quality Management System is designed and implemented in a manner which complies with the relevant GMP and regulatory requirements.
Ensure that appropriate regulatory approval is in place prior to the commencement of production.
activities for each class of product (where required).
Ensure that approved specifications, artworks, procedures, test methods, master batch records and other necessary documentation exists to fully define and control each GMP related operation at the site and where appropriate for operations carried out by third parties.
Ensure that Quality Technical Agreements are established with each customer and each
relevant service provider / supplier and that the roles and responsibilities of the parties are clearly defined therein.
Ensure that appropriate systems are in place for the review of completed batch manufacturing records and for the testing (if required) and approval of finished goods before their release for shipment. This includes ensuring that Pharmaceutical Products are reviewed and certified by a Qualified Person prior to their release.
Ensure that Quality Risk Assessments are conducted when required.
Ensure that an appropriate validation / qualification program for the facility, equipment, process and cleaning operations is established.
Ensure that an appropriate training program is established for all employees in all aspects of their job function relevant to GMP.
Management of product recalls and communication with the regulatory authorities, (in collaboration with Qualified Persons and clients)
Management of audits by regulatory authorities and / or customers
Establishment, monitoring, and reporting of Key performance Indicators for the QMS.
Management and execution of the self-inspection and external audit programs
Management of the Computer Systems Quality Assurance
Management Team Responsibilities
Contributing to the strategic development of the company by ensuring that Quality is to the fore as new business opportunities/contracts are evaluated.
Liaise with both new and existing customers to ensure their needs are fully understood. Proactively contribute to identifying opportunities for to add value to the relationship, through problem solving and the provision of additional services.
Stay abreast of changes in the regulatory environment and the broader commercial influences in the pharmaceutical and nutraceutical sectors. Assist the C.E.O. in ensuring that the company strategy is aligned with the opportunities / obstacles these changes may present.
Ensure that the Management Team is kept abreast of any significant changes in the
regulatory environment that may impact the company’s current operating environment or future development plans.
Ensure that all employees maintain a constant vigilance with respect to GMP compliance and product quality.
Ensure that the CEO is kept informed in a timely manner with respect to all significant quality and compliance issues as they occur.
Ensure that the principles of Good Manufacturing Practice (GMP) are understood and always followed.
Ensure that correct gowning and personnel hygiene procedures are always followed.
Ensure that all documentation is completed correctly in a clear and legible manner as required.
Follow the requirements of Standard Operating Procedures (SOP’s), batch records and other quality documentation correctly.
Follow and complete assigned training programs.
Ensure works spaces are always maintained in a clean and uncluttered condition.
Be familiar with and ensure that Health & Safety requirements are complied with.
Gowning & Personnel Hygiene
Control of Quality Documentation
On-going personal development with respect to GMP’s and relevant regulatory affairs.
All Relevant SOPs
For further information on this Senior Clinical QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie.
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