QA Operations Manager -Drug Product
|Job Title:||QA Operations Manager -Drug Product|
|Contact Name:||Laurentina Kennedy|
|Job Published:||over 2 years ago|
The QA Operation Manager Drug Product works closely with colleagues in Process Development, Supply Chain Operations, Quality Assurance and CMC-Regulatory Affairs while serving as a key point of technical contact between and multiple contract service providers.
At least 5 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology
The QA Drug Product Manager CMO EU will serve as a key knowledge link between Process Development, Supply Chain Operations and other technical services groups, providing technical support for quality systems governing GMP manufacturing (e.g., deviations, investigations, CAPA and change control), regulatory submissions, and facility inspections.
In addition, the QA Manager Drug Product will serve as technical review/approval for manufacturing related documents such as Change Notifications, APQR and MBR.
Coordinate global technical (CMC) support activities for Biologic Drug Product at registration and post-registration stages of the product lifecycle, including troubleshooting, process improvement, cost reduction, capacity expansion, technical transfer, and validation.
Reporting to: Drug Product - Manager CMO EU
Education & Qualifications
Degree in technical/scientific education, pharma.
6 Sigma and Statistical knowledge is an advantage.
Broad knowledge and experience within the GMP environment, and regulatory affairs.
Successful track record of change management projects and processes
High level of customer orientation and organisational skills
Flexible in mind / out of the box thinking
Enthusiastic, decisive, motivating and convincing personality
International background appreciated
Excellent communication skills, verbal and written communication skills
Ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy.
Knowledge and experience relating to the application of Quality by Design principles and statistical analysis tools for evaluation of Drug Product manufacturing processes.
Strong interpersonal skills, with the ability to interact professionally and effectively with peers, managers, and leaders within and outside.
Strong oral and written communication skills, including the ability to deliver presentations and prepare high-quality technical documents.
Effective program management/leadership skills.
Ability to anticipate technical issues and proactively develop creative solutions to ensure that projects stay on schedule.
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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