We&#**Apply on the website**;re looking for a candidate to this
position in an exciting company.
* Development of validation plans, process performance
qualifications for vial and syringe filling.
* Ensuring all aspects of activity within any given process
validation adheres to required policies and procedures, including
safety and training.
* Ensure that the site meets the quality requirements of its
customers and applicable regulations (FDA, EU & international
standards) with a full understanding of CMC business process related
to technology transfer.
* Participate in process validation cross functional teams at the
site to ensure adherence to required policies and procedures and be
responsible to deliver against organizational goals and project
milestones.
* Pre-approve and post-approve process validation protocols and
assessments from a quality system documentation perspective.
* Actively communicates across functions and sites and is a strong
collaborator with all the functional groups at the receiving site,
sending site and corporate functions.
* Act as the responsible point contact from ADL site for the
transfer project for drug product teams and Global Operations Teams.
* Assist in the development of any existing validation program to
ensure continued compliance to the necessary regulations and input to
site validation guidance documents.
* Collate and report on relevant shipping and filter validation.
* Assist in deviation and exception resolution and root cause
analysis.
* Contribute to product quality assessments and process flow
documents.
* Third level Bachelor&#**Apply on the website**;s degree in
science, engineering or a relevant quality discipline with 5
years&#**Apply on the website**; experience in a similar role OR
Master&#**Apply on the website**;s degree & 3 years of directly
related experience OR Associate&#**Apply on the website**;s degree &
**Apply on the website** years of directly related experience.
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written
communications skills.
* 5 + years of experience in support of Commercial Protein Drug
Product (DP) processing in specific areas such as sterile processing,
process characterization, tech transfer (to commercial DP sites) or
validation.
* Strong skills in applying fundamental engineering and scientific
principles to the design, implementation and process validation of
protein freeze-thawing, filtration, mixing, filling (PpK / batch
homogeneity) and/or lyophilisation processes. Knowledge of protein
biochemistry with regard to chemical and physical stability.
* Project management skills including the ability to manage multiple
projects and evaluate project resource requirements.
* Strong knowledge of Quality systems, Drug Product Manufacturing
and Validation.
* Demonstrated ability in providing leadership to cross-functional
teams to advance complex projects to completion. Excellent
Communication skills are essential for this role.
Position: Tech Transfer Lead (Senior)
We&#**Apply on the website**;re looking for a candidate to this
position in an exciting company.
* Development of validation plans, process performance
qualifications for vial and syringe filling.
* Ensuring all aspects of activity within any given process
validation adheres to required policies and procedures, including
safety and training.
* Ensure that the site meets the quality requirements of its
customers and applicable regulations (FDA, EU & international
standards) with a full understanding of CMC business process related
to technology transfer.
* Participate in process validation cross functional teams at the
site to ensure adherence to required policies and procedures and be
responsible to deliver against organizational goals and project
milestones.
* Pre-approve and post-approve process validation protocols and
assessments from a quality system documentation perspective.
* Actively communicates across functions and sites and is a strong
collaborator with all the functional groups at the receiving site,
sending site and corporate functions.
* Act as the responsible point contact from ADL site for the
transfer project for drug product teams and Global Operations Teams.
* Assist in the development of any existing validation program to
ensure continued compliance to the necessary regulations and input to
site validation guidance documents.
* Collate and report on relevant shipping and filter validation.
* Assist in deviation and exception resolution and root cause
analysis.
* Contribute to product quality assessments and process flow
documents.
* Third level Bachelor&#**Apply on the website**;s degree in
science, engineering or a relevant quality discipline with 5
years&#**Apply on the website**; experience in a similar role OR
Master&#**Apply on the website**;s degree & 3 years of directly
related experience OR Associate&#**Apply on the website**;s degree &
**Apply on the website** years of directly related experience.
* Knowledge of cGMPs and other worldwide regulatory requirements.
* Problem solving ability and excellent oral and written
communications skills.
* 5 + years of experience in support of Commercial Protein Drug
Product (DP) processing in specific areas such as sterile processing,
process characterization, tech transfer (to commercial DP sites) or
validation.
* Strong skills in applying fundamental engineering and scientific
principles to the design, implementation and process validation of
protein freeze-thawing, filtration, mixing, filling (PpK / batch
homogeneity) and/or lyophilisation processes. Knowledge of protein
biochemistry with regard to chemical and physical stability.
* Project management skills including the ability to manage multiple
projects and evaluate project resource requirements.
* Strong knowledge of Quality systems, Drug Product Manufacturing
and Validation.
* Demonstrated ability in providing leadership to cross-functional
teams to advance complex projects to completion. Excellent
Communication skills are essential for this role.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
