Validation Team Leader role in Start up Pharmaceutical in Waterford
City. Reporting to the Head of Engineering the overall Purpose of this
role is ?
* To ensure equipment is maintained in a validated state meeting cGMP
requirements. ?
* Development, deployment and improvement of validation processes to
ensure the maximum levels of performance and compliance are maintained
_RESPONSIBILITIES_ will include:
-Health, Safety and the Environment ?
* Comply at all times with the Health, Safety and Environmental policy
and associated procedures. ?
* Continuously promote a positive safety culture by challenging
yourself and others to prioritize safety in everything you do.
Quality Compliance ?
* Ensure all work carried out, is in compliance with the required
standards, conforming to company, cGMP, cGLP, SOP?s and regulatory
guidelines. ?
* Take ownership for quality compliance in all activities you are
responsible for.
Engineering ?
* Ensuring approaches are aligned with current guidelines (ICH/ASTM
etc). ?
* Integrating as far as possible Engineering activity and validation
activity. ?
* Developing procedures and processes which ensure Validation activity
is integrated into process design and Engineering execution in new
projects and processes. ?
* Develop the site validation schedule and ensure it is scalable in
the event of future additions. ?
* Develop validation protocols as required ensuring at all times that
acceptance criteria is clear and related to process capability. ?
* Ensure the site change control procedure is integrated into
documentation and procedures. ?
* Manage internal and if necessary external outsourced routine
requalification of process equipment. ?
* Represent the validation strategy and validation results in audits
as required. ?
* Benchmark other industries and organizations to ensure best practice
is in use. ?
* Be active in the network, attending conferences/training seminars as
needed.
The ideal candidate will have:
- * Qualified to a minimum of Degree level in engineering or related
discipline ?
* Minimum 5 year?s Validation Engineering experience within a
relevant Pharma. environment (preferably within a sterile
manufacturing environment) ?
* Proven track record in the industry in process validation and the
development of procedures and processes to support best practice.
CALL CLAIRE GROGAN FOR A CONFIDENTIAL CHAT ON THIS ROLE AND OTHER
ROLES NO
W OPEN IN THIS EXCITING NEW MULTINATIONAL COMPANY IN WATERFORD Validation Team Leader
Validation Team Leader role in Start up Pharmaceutical in Waterford
City. Reporting to the Head of Engineering the overall Purpose of this
role is ?
* To ensure equipment is maintained in a validated state meeting cGMP
requirements. ?
* Development, deployment and improvement of validation processes to
ensure the maximum levels of performance and compliance are maintained
_RESPONSIBILITIES_ will include:
-Health, Safety and the Environment ?
* Comply at all times with the Health, Safety and Environmental policy
and associated procedures. ?
* Continuously promote a positive safety culture by challenging
yourself and others to prioritize safety in everything you do.
Quality Compliance ?
* Ensure all work carried out, is in compliance with the required
standards, conforming to company, cGMP, cGLP, SOP?s and regulatory
guidelines. ?
* Take ownership for quality compliance in all activities you are
responsible for.
Engineering ?
* Ensuring approaches are aligned with current guidelines (ICH/ASTM
etc). ?
* Integrating as far as possible Engineering activity and validation
activity. ?
* Developing procedures and processes which ensure Validation activity
is integrated into process design and Engineering execution in new
projects and processes. ?
* Develop the site validation schedule and ensure it is scalable in
the event of future additions. ?
* Develop validation protocols as required ensuring at all times that
acceptance criteria is clear and related to process capability. ?
* Ensure the site change control procedure is integrated into
documentation and procedures. ?
* Manage internal and if necessary external outsourced routine
requalification of process equipment. ?
* Represent the validation strategy and validation results in audits
as required. ?
* Benchmark other industries and organizations to ensure best practice
is in use. ?
* Be active in the network, attending conferences/training seminars as
needed.
The ideal candidate will have:
- * Qualified to a minimum of Degree level in engineering or related
discipline ?
* Minimum 5 year?s Validation Engineering experience within a
relevant Pharma. environment (preferably within a sterile
manufacturing environment) ?
* Proven track record in the industry in process validation and the
development of procedures and processes to support best practice.
CALL CLAIRE GROGAN FOR A CONFIDENTIAL CHAT ON THIS ROLE AND OTHER
ROLES NO
W OPEN IN THIS EXCITING NEW MULTINATIONAL COMPANY IN WATERFORD
We need : English (Good)
Type: Permanent
Payment:
Category: Others
