Job ID: JOB-11958
We are now recruiting a Stability Coordinator to join our clients diverse Quality team in Dublin. The Stability Program Coordinator is responsible for the administration of the stability program which includes creating stability protocols, scheduling of the stability sample pull points, monitoring environmental stability storage chambers and setting the samples down on stability according to the relevant procedures.
The position incumbent is expected to adhere to all cGMP compliance and regulatory mandates and quality requirements, and comply with all SOPs and internal policies and procedures in the performance of job duties. The Stability Program Coordinator applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality, and/or the fulfillment of the assigned performance targets. The Stability Program Coordinator is responsible for the safe, compliant, and efficient execution of job duties in a team environment. This position reports to the QC Stability Supervisor and may act as his/her deputy as deemed necessary.
Primary duties and responsibilities of the position are as follows. Other duties may be assigned.
- Write EDOCs stability protocols
- Write and approve LIMs stability protocols.
- Perform sample management through LIMS (i.e. logging samples, labelling samples, updating inventory, placing samples in chambers, removing samples from chambers and destruction of samples from completed study) as per the relevant procedure
- Run weekly stability pull schedule as per the relevant procedure
- Co-ordinate the sending of stability samples to contract testing sites and managing stability data from these sites
- Liaising with contract stability sample storage sites
- Stability room management as per the relevant procedure
- Approval of the stability data with the LIMs system and signing the stability reports
- Filing and archiving of the stability data
- Evaluate stability trends and prepare reports
- Initiate action reports or deviation reports for any applicable nonconformance
- Writing the annual stability assessment reports.
- Liaise with QA, warehouse, packaging sites and pharma tech group.
- Maintain data integrity and ensure compliance with FDA, GLP, cGMP regulations, as well as with company SOPs and ICH guidelines.
- Observe established escalation process for issues that impact the stability program
- Author documents that ensure cGMP compliance, such as laboratory investigation, deviations, change controls, change notices, and sops relating to the stability program
- Seek process innovation and continuous process improvements
- Recognize and report to immediate supervisor any issues or deviations from accepted standards.
- Provide status updates on own activities and productivity challenges according to defined procedures.
- Complete and conform to all training requirements for job role, including company-required and job role-specific training.
- Carry out and assist in the ongoing training of new and existing personnel, as appropriate.
- Observe all safety and compliance procedures and actively highlight any safety concerns to help drive the reduction of accidents or near misses.
- A third level qualification in Chemistry or related Science, preferably a Bachelor’s Degree
- Bachelor’s Degree in Science or related discipline
- Strong knowledge of LIMS, knowledge of Stability Module would be an advantage
- EDOCS experience, Excel, mini-tab or other stats packages
- Experience in stability testing or stability program administration preferred
- Excellent communication and interpersonal skills, including technical writing
- Strong analytical and problem solving skills
- Maintain credibility and integrity.
- Goal focused
- Demonstrate passion and energy
- Experience in pharmaceutical manufacturing facility.
- Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory.
- Knowledge of microbiology testing and analysis is a plus;
- Knowledge of FDA guidelines on Stability requirements is a plus;
- Must be flexible and able to handle multiple activities
Technical Skills and Experience:
Computer literate; proficiency in using LIMS systems and Microsoft Office suite
- Exhibits a high personal drive for excellence and holds self-accountable for consistently high quality performance results.
- Understands the vision, strategy, and goals of one’s own function and of the site, and adeptly evaluates, plans, and prioritises own work accordingly, creating efficient workflows to manage multiple activities and using time and resources effectively to deliver expected results on or before deadline.
- Demonstrates a commitment to innovation and continuous improvement by engaging in an ongoing assessment of processes and generating ideas and recommendations for increasing quality and efficiency.
- Demonstrates ability to perform effectively under pressure and challenging conditions, maintaining focus and intensity and remaining optimistic and persistent while working to achieve expected results.
- Models open communication and information-sharing, consistently keeping all stakeholders informed of own
For further information on this role in Dublin please contact Emma Griffin on email@example.com
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