a Biologics or similar GMP environment as part of an engineering,
technical services or operations function?
This is a contract role based in Louth.
If interested, please send your CV to * or call
Karen on + *- *.
QA VALIDATION SPECIALIST - BIOTECH - LOUTH
JOB DESCRIPTION
Our client is a leading international biotech company with a state of
the art manufacturing facility in Louth.
Reporting to the Associate director of QA validation the Sr. QA
Validation Specialist –will be responsible and accountable for
developing the QA validation procedures and ensuring compliance to
legislative and local practices for the review and approval of all
qualification/validation documentation and QA related activities to
the release of facility, utility and equipment for GMP production.
Responsible for preparing the quality review and ensuring all
approvals of qualification/validation documentation, including
computer system validation and associated data for conformance to
regulations, Standard Operating Procedures (SOPs), specifications and
other applicable acceptance criteria.
Develop, write, review and approve SOPs and controlled documents to
support site validation activities and in accordance with client
policies.
Ensure all equipment and processes are safe, effective and qualified
in compliance with industry standards and regulatory expectations.
Oversight for key functional areas (i.e. PEV, QC, Supply Chain,
Engineering, CSV), ensuring that programs, policies and procedures are
robust and in keeping with regulatory and client expectations.
Providing clear expectations regarding validation standards. Report
monthly validation KPIs and
metrics and ensure opportunities for improvement are identified and
actioned accordingly.
Actively participate in the New Product Introduction (NPI) and
technology transfer process and ensure all associated protocols are
conducted and in place in line with project timelines and impact
assessments.
Provide support to team members for more complex processes and
decisions.
In addition, ensure compliance to regulatory, and local protocols.
Lead by example and ensure associated risk assessments are conducted
in line with site expectations and provide a safe working environment
by complying with all pertinent environmental health/safety practice,
rules and regulations.
Liaise actively with other functional areas and provide support to
ensure standards are met.
Ensure corrective action / preventative action measures are put in
place to drive improvement.
Actively participant the internal and external audits regarding
validation processes and protocols.
Represent the organisation in more complex risk and impact
assessments.
Perform all activities in compliance with client safety standards and
SOPs
Participate in other projects/duties as assigned.
Experience in change control, non-conformance, corrective and
preventative actions, and validation practices.
REQUIREMENTS
Minimum of 3 years’ experience working in a Biologics or similar GMP
environment as part of an engineering, technical services or
operations function or other combination of experience and educational
background that may otherwise satisfy the requirements of the role
Previous experience leading an established validation team, working in
a green field environment advantageous.
Experience working in Quality Assurance role in a GMP Life Science
environment.
Demonstrated understanding of principles of Validation and New Product
Introduction and strong knowledge of Computerised System Validation,
Method Validation, Shipping Validation, Cleaning Validation and
Process Validation.
Strong knowledge of GxP regulations (e.g. EU-GMP Guideline, Annex
*/ *, SFDA)
B.Sc or B.Eng in a Scientific or Engineering related discipline
preferred.
Behavioural CompetencieStrong organisational, communication,
coordination, and meeting facilitation skills
Excellent interpersonal, verbal, and written communication skills
Good critical thinking skills and troubleshooting to drive improvement
and build opportunities.
Self-starter and self-motivated; organized with good attention to
detail
Comfortable working in a fast-paced environment and able to adjust
workloads based on changing priorities
Results oriented, with the ability to manage multiple priorities in a
short period of time.
Collaborative and inclusive approach to work and your colleagues.
Engage cross functionally in conjunction with a site-based team.
Must be willing to travel as required internationally to fulfil the
responsibilities of the position.
PACKAGE
Hourly Contract Rate € * - €**Apply on the
website** per hour
We need : English (Good)
Type: Permanent
Payment: EUR 50 - 65 Per Hour
Category: Construction
