Are you an Aseptic Process Owner Lead with *+
years experience with regulatory compliance in cGMP manufacturing and
in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of
Sterile Medicinal Products?
This is a contract role based in Dun Laoghaire, Dublin.
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoghaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing
plant.
An exciting and rare opportunity has presented for an Aseptic Process
Owner Lead.
This is a senior role in the organisation and requires in-depth
technical and operational knowledge of aseptic Drug Product
manufacturing processes; Parts/Components Preparation, Formulation,
Syringe Filling, Vial Filling, Lyophilisation and Capping.
The Site Aseptic Process Owner Lead will continue to build on the site
and network aseptic processing knowledge and represent the Dublin site
at a global level across the manufacturing network.
As the Site Aseptic Process Lead you will be an established
professional who is a self-starter, capable of applying advanced
process knowledge and creativity to complete complex assignments
related to aseptic operations.
You are someone who contributes to the development of new principles
and concepts, who wants to be challenged and can lead change from an
aseptic operations perspective.
Perform as a knowledgeable subject matter expert (SME), and single
point of contact on site and network projects and programs, to advance
aseptic operations
Leading and/or providing input to strategic initiatives that will
improve and develop Manufacturing processes for the future including
Contamination Control and Aseptic Process Simulations (APS)
Contribute in a team environment to operational issues pertaining to
processes as they arise and provide expertise and support to help
resolve escalated technical issues as required
Remain current on state-of-the-art for systems and processes and
advise on the appropriate adoption and use of new techniques and
technology.
Involved in the daily business management systems and reporting, have
a clear understanding of what is happening in the assigned area of
responsibility. Monitor any process trends (Personnel and
Environmental Monitoring), including business performance metrics.
Identify actions that will enable the process and the Manufacturing
areas better achieve and surpass metrics in the future
Lead and/or Support investigations that impact on safety, quality
and/or compliance of the processes, ensuring thorough investigations
are conducted and actionable CAPAs, to prevent future reoccurrence,
are implemented within agreed timelines
REQUIREMENTS
Bachelor’s degree in Microbiology or related discipline with **Apply
on the website** + years’ experience in the pharmaceutical industry
Experience with regulatory compliance in cGMP manufacturing and
in-depth knowledge of Eudralex Volume 4, Annex 1 Manufacture of
Sterile Medicinal Products.
Proven ability to work in a high paced matrix organization and
effectively influence change and escalate issues professionally and in
a timely manner
Excellent Decision-Making skills and confidence to challenge others
respectfully and professionally on decisions that impact the
manufacturing area
Proactive and works well with others in a collaborative, fast-paced
goal-driven environment
Interacts well with diverse groups (Manufacturing, Validation,
Engineering, Quality etc) and maintains strong working relationships
with internal and external collaborators
Demonstrated ability to coach, mentor and/or cross train colleagues
within core technical areas
Excellent verbal and written communication skills:
Strong Technical writing skills for cGxP documentation (e.g.
investigations, procedures, change controls) and good Presentation
skills.
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract with the possibility
of an extension.
Onsite expectations: The team are required to do a minimal 3 days per
week onsite.
However, the initial expectations are for you to be more present
onsite to help integrating into the team, familiar with the site and
projects, and benefit from face-to-face time and meetings.
Depending on their capabilities and speed of development, the
long-term goal is to offer 3 days onsite per week.
We need : English (Good)
Type: Permanent
Payment: EUR 50 - 60 Per Hour
Category: Construction
