QA Team Leader Compliance
1 month ago
The role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and regulatory systems.
The role will support and ensure that the site and related functions are in compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have ownership for key quality system elements and will support and execute site quality and compliance improvements, working closely with relevant stakeholders on site
Role
- Compliance governance of key quality system elements, including scheduling and completion of; Quality Management Reviews, Qualification of Vendors, PQRs, Audits (Self-Inspections, Vendor Audits, Customer Audits).
- Maintain site establishment registrations with regulatory agencies as applicable.
- Coordinate tracking of site compliance commitments and follow up actions. Coordinate and support the delivery of Quality Compliance Metrics/KPIs to key stakeholders.
- Identify GxP trends and communicate these to relevant stakeholders. Support compliance risk management activities and implementation of risk mitigation plans.
- Working with the wider site functions to drive down out of compliance events, identify and implement quality improvements
- Coordinate QMS training for site employees and ensure this adheres to current regulatory requirements
- Maintain responsibility as the site system owner for the Trackwise electronic QMS
- Support and track regulatory findings and trends that may lead into a focus of regulatory inspections
- Act as Single Point of Contact between site and Corporate Quality Team as delegated by QA Manager
- Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance.
- Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.
- Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.
- Support effective pre-audit preparation, management and post audit follow up of customer audits and regulatory inspections.
- Escalate any significant breach of quality or regulatory compliance to the QA Manager (Compliance) and Head of Quality.
- Keep up to date and integrate current quality standards, guidelines and best practice on site. Ensure compliance by promoting understanding of the underlying concepts
- Ensure productive working relationships are maintained between QA and other site personnel and stakeholders.
-
QA Team Leader Compliance
1 week ago
Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
4 weeks ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
3 weeks ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
4 weeks ago
Grangemouth, Scotland, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
4 weeks ago
Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of quality and...
-
QA Team Leader Compliance
1 month ago
Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full timeJob Description The role of the QA TL (Compliance) is to ensure governance and compliance of the Pharmaceutical Quality Management System (PQS) and maintain Regulatory Registrations/Licenses/Certifications at Piramal Grangemouth. The position holder will have responsibility to coordinate, maintain and promote compliance, leading continuous improvement of...
-
QA / Qc Inspector
4 days ago
Grangemouth, United Kingdom Bilfinger Full time**QA / QC inspector** Location: GRANGEMOUTH Bilfinger UK is a leading engineering and maintenance provider, supporting customers across the chemical & petrochemical, nuclear, oil & gas, pharmaceuticals & biopharma, power & energy, utilities, renewables and food & beverage markets. We enhance the efficiency of assets, ensuring a high level of availability...
-
QA Officer
2 weeks ago
Grangemouth, United Kingdom CW Recruitment Specialists Full timeJob Purpose: Act as a QA representative for new products and for change projects, dealing with review/approval of process instructions, change controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition. **Key duties include**: - Collaborate with internal and external stakeholders to ensure...
-
Compliance and Assurance Auditor
3 weeks ago
Grangemouth, United Kingdom INEOS Grangemouth Full time**Hours: 37.5**: Location: Grangemouth **Salary**: Competitive Contract type: Permanent **ABOUT US**: **Are you in?**: A truly global company, INEOS comprises of 36 businesses with 194 sites in 29 countries throughout the world. We also encompass a range of consumer brands and sports interests. We pride ourselves in offering a working environment that is...
-
Compliance Officer
1 month ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications.nThe role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines,...
-
Compliance Officer
2 months ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications.The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines,...
-
Compliance Officer
3 months ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications.The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines,...
-
Compliance Officer
1 month ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications.The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines,...
-
Compliance Officer
2 months ago
Grangemouth, United Kingdom Piramal Pharma Solutions Full timeThe role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications. The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines,...
