:
Hybrid but required to be flexible in this regard
Need experience in sterile or aseptic environment - min 3 years but ideally more
Supervisor – Quality Assurance Team Lead.
Duties and Responsibilities:-Batch
Record Review and material release (including
CoA) to ensure compliance with GMP requirements.
-Quality review and approval of Master Batch Record
(MBR) record for routine cleaning and process activities,
including Automation recipe updates.
-QA Review and Approval of SOPs, Work Instructions and
forms from other departments.
-Attendance at Daily/Weekly Operations led Team
Meetings.
-Responsible for Gemba Walkdowns & Inspection
Readiness Walkdowns from a QA perspective.
-QA review and approval of Warehouse Shipping Picklist.
-Primary QA point of contact for Quarantine Shipments.
-Responsible for Batch Book Filing & Archival.
-QA review and approval of quality non-conformance
(NC) records and customer complaint non-conformance
records.
-Initiation and ownership of QA non-conformance
records.
-Responsible for periodic review of Quality Assurance
and Quality Systems SOPs.
-Primary Quality point of contact for attendance at Root
Cause Analysis meetings.
-Primary QA point of contact for the Returns process.
Minimum Requirements:Key
Skills and Competencies Required:-Builds
strong productive relationships.
-Demonstrates ability to work with teams and individuals.
-Seeks opportunities to grow and develop professionally.
-Uses best practices to improve business operations.
-Holds self-accountable for compliant and flawless
execution.
-Takes personal responsibility for decisions that
successfully build customer value.
-Effectively manages and adapts to change.
-Always demonstrate Integrity and Credo-based actions.
-Ability to work independently, manage their own time and
meet deadlines as appropriate.
Education and Experience:-Third
level Degree in a science or pharmaceutical
discipline.
-A minimum of 3 years of experience within the
Pharmaceutical Industry.
-A working knowledge of quality processes and systems
is desirable.
-Demonstrated knowledge and application of industry
regulations including those of FDA, HPRA, EMEA and
other authorities.
NOTE
We are hiring for our clients diversability programme, so candidates with physical and hidden disabilities, mental health conditions or neurodivergence are invited to apply. If you don't have a disability we can still register you for our traditional SourcePro hiring programme.
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SourceAbled, a proprietary workforce solution powered by Rangam, goes beyond a traditional job placement program. It provides a collaborative, holistic solution implemented to develop an inclusionary program and a culture of belonging by matching Fortune 500 companies with diverse talent seeking to build and sustain successful and fulfilling careers.
SourceAbled connects individuals with autism, neurodivergence and physical disability, to apply for jobs with employers in the USA, UK, Ireland, Europe and India, who are actively seeking talents with disabilities. SourceAbled facilitates the coordination and management of diverse hiring programs, with a consultative approach, including training, and brings them to life through digitizing the experience of attracting, onboarding, supporting, and retaining qualified employees with autism and disabilities. The program uses an end-to-end, tech-enabled hiring program to build a connected inclusive community in the workplace for neurodivergent talent. It is designed to attract and place qualified job seekers as businesses look to establish, build, and maintain their disability inclusion practices and establish and nurture a culture of inclusion.
It is the policy of Rangam Consultants, Inc. to provide equal employment opportunities to all applicants and employees without regard to any legally protected status such as race, color, religion, gender, national origin, age, disability or veteran status.
Job Type: Full-time
Pay: €40.00 per hour
Expected hours: 40 per week
Application question(s):
* Experience in sterile or aseptic environment?
* GMP
* SOP
Education:
* Bachelor's (preferred)
Work authorisation:
* Ireland (required)
Willingness to travel:
* 75% (required)
Work Location: In person