The current position I hold, Regulatory Compliance Manager, was vacated as the previous position holder was promoted to QA Director for the facility. Following their promotion I was approached and asked if I was interested in taking this position, which I had accepted. I was employed in the same company as a Supervisor in the QC Chemistry department for three years prior to this.
Describe a typical day?
In a typical day I complete a review and approval of a number of quality documents such as deviations, standard operating procedures, validation protocols and reports, product manufacturing procedures and records. I participate in a number of meetings at the facility and provide quality input into decisions made at the site.
As I have responsibility for adherence to the regulatory standards and guidelines governing the manufacture of medicinal products all documentation for quality review and approval must be thoroughly reviewed for completeness and accuracy.
Timescales and pressures are driven by both the production schedule in addition to those expected from regulatory agencies. Timelines must be strictly adhered to and are monitored continuously. The metrics associated with the management and performance of the quality system fall under my area of responsibility.
Monitoring these metrics is important as quality decisions made at the facility are generally driven by the output of these metrics.
What are the main tasks and responsibilities?
As Regulatory Compliance Manager I have responsibility for the following areas:
Product Complaint investigations
GMP (Good Manufacturing Practices) training
Adherence to medical and pharmaceutical industry regulatory requirements driven by the Irish government medical agency, European medicines agency and the US Food and Drug Administration.
Preparation for regulatory agency inspections is an important aspect of this position.
Ensuring the facility is adequately prepared for an inspection, results in renewal of the facility license to operate by the Irish Medicines Board.
Adherence to the regulatory standards and guidelines by all personnel at the facility is a big responsibility and one which requires interaction with all departments at the site.
What are the main challenges?
The pharmaceutical industry is constantly changing, driven by both increases in the standards at other companies in the industry in addition to changing regulatory requirements. Ensuring that the company in which you are employed stays current with existing and proposed legislation updates is a challenge.
What's cool?
The pharmaceutical industry changes constantly, with see regulatory requirements and new technology created continuously. The industry in Ireland is quite small and through a number of channels companies share information about changing technology at their facilities.
Keeping up to date with changes in the industry is interesting. Becoming familiar with new technologies/changes ensures that the job remains interesting.
What's not so cool?
It can be a challenge dealing with the level of documentation associated with the processes in the pharmaceutical industry
What particular skills do you bring to your workplace?
Organisation skills. Ability to stay focused on specific task. Attention to detail
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