We are currently looking for a Prinicipal QA Specialist to join a leading Pharmaceutical company based in the Berkshire area. As the Prinicipal QA Specialist, you will be responsible for operating as the Quality SME on site for SQC preparation, Deviation process including Track & Trend, quarterly reports, monthly emails, event category limits, QRM process and PQS tools.
This is for an initial 12 months, with possible extension.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Prinicipal QA Specialist will be varied; however, the key duties and responsibilities are as follows:
1. As the Prinicipal QA Specialist, you will prepare and coordinate monthly SQC slides and summaries, finalise meeting minutes, and publish in the local DMS system.
2. As the Prinicipal QA Specialist, you will Manage the deviation process, including Track & Trend, quarterly reports, and monthly emails. Act as the main point of contact for audit observations and CAPAs.
3. As the Prinicipal QA Specialist, you will Ensure the QRM process aligns with global standards, providing strategic expertise and resolving escalated issues.
4. As the Prinicipal QA Specialist, you will Utilise PQS statistic tools for data preparation, statistical analysis, and supporting business compliance.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Prinicipal QA Specialist, we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science or QA discipline.
2. Proven industry experience in quality assurance within the pharmaceutical sector, ideally at a Principal / SME / Team Lead level and within a Biologics / Biopharmaceutical or Cell and Gene Manufacturing facility.
3. A working knowledge and practical experience with GMP and quality processes.
Key Words: / Quality Assurance / Pharmaceutical / GMP / Compliance / Deviation Management / QRM / SQC / CAPA / Continuous Improvement / Quality Metrics / CAPA / Deviation / Chane Controls / GMP / cGMP / Pharma / Biopharma / Biopharmaceutical / CGT / C> / Cell and Gene Therapy
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
This is for an initial 12 months, with possible extension.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Prinicipal QA Specialist will be varied; however, the key duties and responsibilities are as follows:
1. As the Prinicipal QA Specialist, you will prepare and coordinate monthly SQC slides and summaries, finalise meeting minutes, and publish in the local DMS system.
2. As the Prinicipal QA Specialist, you will Manage the deviation process, including Track & Trend, quarterly reports, and monthly emails. Act as the main point of contact for audit observations and CAPAs.
3. As the Prinicipal QA Specialist, you will Ensure the QRM process aligns with global standards, providing strategic expertise and resolving escalated issues.
4. As the Prinicipal QA Specialist, you will Utilise PQS statistic tools for data preparation, statistical analysis, and supporting business compliance.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Prinicipal QA Specialist, we are looking to identify the following on your profile and past history:
1. Relevant degree in a Science or QA discipline.
2. Proven industry experience in quality assurance within the pharmaceutical sector, ideally at a Principal / SME / Team Lead level and within a Biologics / Biopharmaceutical or Cell and Gene Manufacturing facility.
3. A working knowledge and practical experience with GMP and quality processes.
Key Words: / Quality Assurance / Pharmaceutical / GMP / Compliance / Deviation Management / QRM / SQC / CAPA / Continuous Improvement / Quality Metrics / CAPA / Deviation / Chane Controls / GMP / cGMP / Pharma / Biopharma / Biopharmaceutical / CGT / C> / Cell and Gene Therapy
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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