: Responsible for overseeing a team of QA employees and their
prospective area(s) and/or assignments.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO,
THE FOLLOWING:
?Responsible for all aspects of QA Team including review and
approval of the following types of documents, relating to area
functions:
- Master records
- executed records
- failure investigations
- Change Controls
-SOPs
- Validation protocols and summary reports
- Incursions
?Approves various documents relating to area function, including
those listed above.
?Organizes QA resource assigned to functional area to meet goals and
timings; coordinates prioritization of activities with area
management.
?Performs compliance monitoring of area operations, including
trending of failures and evaluating effectiveness of corrective
actions.
?Reviews customer requirements and implements required processes, as
needed, to meet customer expectations regarding Quality.
?Participates in regulatory and customer audits. Interfaces with
customer/partner quality organizations.
?Participates on internal committees/teams, as required.
?Provides advice and direction to other company departments on
quality and regulatory issues.
?Acts as an auditor on behalf of Regeneron Ireland.
EDUCATION AND EXPERIENCE:
?BS in life sciences discipline or related field (chemistry,
biology, or pharmacy preferred) with experience in a
pharmaceutical/biologics manufacturing environment desired. Minimum 7
years? experience in pharmaceutical industry with 2+ of those years
to include leadership and/or supervisory experience.
?Eligibility to act as a Qualified Person (QP) in accordance with EU
directives preferred.
?Experience in startup operations an advantage.
SUMMARY
: Responsible for overseeing a team of QA employees and their
prospective area(s) and/or assignments.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO,
THE FOLLOWING:
?Responsible for all aspects of QA Team including review and
approval of the following types of documents, relating to area
functions:
- Master records
- executed records
- failure investigations
- Change Controls
-SOPs
- Validation protocols and summary reports
- Incursions
?Approves various documents relating to area function, including
those listed above.
?Organizes QA resource assigned to functional area to meet goals and
timings; coordinates prioritization of activities with area
management.
?Performs compliance monitoring of area operations, including
trending of failures and evaluating effectiveness of corrective
actions.
?Reviews customer requirements and implements required processes, as
needed, to meet customer expectations regarding Quality.
?Participates in regulatory and customer audits. Interfaces with
customer/partner quality organizations.
?Participates on internal committees/teams, as required.
?Provides advice and direction to other company departments on
quality and regulatory issues.
?Acts as an auditor on behalf of Regeneron Ireland.
EDUCATION AND EXPERIENCE:
?BS in life sciences discipline or related field (chemistry,
biology, or pharmacy preferred) with experience in a
pharmaceutical/biologics manufacturing environment desired. Minimum 7
years? experience in pharmaceutical industry with 2+ of those years
to include leadership and/or supervisory experience.
?Eligibility to act as a Qualified Person (QP) in accordance with EU
directives preferred.
?Experience in startup operations an advantage.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
