Plant Quality Assurance (PQA) Snr Associate
Posted on :
22-10-2022
Employer Active
1 Vacancy
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Jobs by Experience
3-5 years
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
22-10-2022
Job Description
Req ID : 1641747
Job Title:Plant Quality Assurance (PQA) Snr Associate A32151
About the Company:
Our client is a Multinational Biopharmaceutical company with more than 20,000 employees worldwide and approximately 500 workers in its D n Laoghaire (co. Dublin) facility, which is a 37,000-square-metre aseptic operations facility with freeze-dry product (lyophilization) and liquid vial-filling capabilities.
Its Irish site specializes in secondary manufacturing activities formulation, fill, and packaging, and also includes a bioprocessing suite and laboratories. The local team is currently engaged in one of the largest and fastest technology transfer programs in the company s history. Make a difference in the lives of others, working at the forefront of biotechnology with the top minds in the field.
Job Summary:
The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
This is a 24/7 shift role required to support manufacturing operations -12hr shift role - Eye Test Required for this position - Inspection Role.
Job Duties:
- Perform all activities in compliance with company safety standards and standard operating procedures.
- Observe and provide real-time quality oversight and support for manufacturing on the floor.
- Perform purposeful presence on the floor audits.
- Perform manual visual inspection AQL audits of vials and syringes.
- Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations
- Certification of defect panels.
- Provide quality support for triage and investigation of all classes of deviation events.
- Review/approve deviations for closure ensuring compliance with appropriate standards.
- Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
- Provides training and advice to staff in order for them to perform their desired functions.
- Write, review and approve standard operating procedures in accordance with company policies.
- Support continuous improvement and operational excellence initiatives
- Any other tasks/projects assigned as per manager s request.
Requirements
Basic Qualifications & Experience:
- University degree. Engineering or Science related discipline preferred.
- Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience:
- Excellent written and verbal communication skills.
- Experience working with dynamic cross-functional teams and proven abilities in decision making.
- Strong organizational skills, including ability to follow assignments through to completion.
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
- Experience working in aseptic operations, protein formulation, vial and syringe filling.
- Knowledge ofapplicable Regulatory requirements, and ability to evaluate compliance issues.
*** No Visa Processing ***
Benefits
Benefit from Independent Solutions ethical principles!
We look after our team, we know the business, we have been working in the sector >20 years. We are not a recruitment agency
While placed on client sites you will be an integral part of our team, gaining support and access to the knowledge and experience of our cross functional LifeScience team
We offer attractive rates - competitive margins compared to our competitors
Payment on time and in full
We continue to partner and grow our client base and thereby ensure that we have a continuous supply of High-Value Projects
We work for you!
Basic Qualifications & Experience: University degree. Engineering or Science related discipline preferred. Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications & Experience: Excellent written and verbal communication skills. Experience working with dynamic cross-functional teams and proven abilities in decision making. Strong organizational skills, including ability to follow assignments through to completion. Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations. Experience working in aseptic operations, protein formulation, vial and syringe filling. Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues. *** No Visa Processing ***
Employment Type
Full Time
Key Skills
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