Orion Group Life Sciences are currently recruiting a QC Microbiology Analyst on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.
Role Functions:
Perform and support QC analytical activities including in-process, release and stability related testing.
Provide day to day direction and scheduling to the QC analyst team.
Responsible for the qualification, maintenance, and/or integration of the QC methods, in compliance with up-to-date data integrity, regulatory, and industry standards.
Responsible for driving a culture of Continuous Improvement.
Ensure that cGMP standards are maintained at all times.
Accountable for change control process and mechanisms required to maintain a state of continued compliance for the methods.
Manage deviations, CAPAs and change controls.
Author/review technical documents, standard operating procedures and actions for the performance of laboratory methods.
Participate in risk assessments and implement and follow-up on corrective / preventative measures.
Serve as an SME for regulatory and internal inspections and audits.
Work cross-functionally to build and operate testing capability within the lab.
Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.
The motivation to be an inspiring member of a high performing team.
The desire to continuously learn, improve and develop.
Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.
Writing and updating SOPs.
Ensure training is current for all job functions performed
Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations
Experience:
5 years industry experience with significant knowledge and experience working in a Microbiology Laboratory in a pharmaceutical company
Experienced in testing as per the pharmacopeia's
Working knowledge of QC Digital Systems (eLogs, Electronic Lab Notebook, LIMS etc.)
Skills:
Ability to respond to changing priorities
Strong organisational skills
Good verbal and written communication skills
Excellent troubleshooting and problem-solving skills
Good attention to detail
Ability to think logically and be proactive
Ability to work as part of a team and on own initiative in a constructive manner
Flexible and self-motivated
Our role in supporting
diversity
and
inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group.
We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion.
In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.