Quality Systems Lead

4 weeks ago


Morpeth, United Kingdom Piramal Pharma Solutions Full time

To lead a team that collectively, is responsible for administering and delivering the Pharmaceutical Quality System (PQS) across the Morpeth facility.

Maintain and develop systems and processes that proactively keep the site ahead of the curve in changes to legislation, technology and risk-based approaches. Drive a quality culture within the business that embraces continuous improvement.

Key Roles/Responsibilities Include:

- Lead and develop a team to deliver a robust, supportive, Quality System for the organisation that complies with ICH (Q7, Q9 & Q10), CFR 210 & 211, EU GMP and UK GMP.
- In conjunction with the Head of Compliance and Technical Quality, manage and develop the following systems and processes on site:

- Deviations
- Investigations (using RCA tools)
- CAPAs
- Change Controls
- Effectiveness Reviews
- Extension Requests
- Internal Audit (formal self-inspection and informal Gemba)
- External Audit (by clients and regulatory authorities)
- Quality Complaints
- Product Quality Reviews
- Quality Technical Agreements
- Quality Risk Management
- Quality Metrics and KPIs
- Risk Register and Assessments
- Self-Inspection Audits
- Periodic GMP Training
- Is considered to be the Subject Matter Expert for many of the aforementioned areas.
- Support the following activities:

- Document Control
- Vendor Assurance
- Customer projects and audits
- eCompliance projects
- Pest Control provisions
- Audit / Inspection readiness
- Act as the site’s Data Integrity Compliance Officer, tracking any remediation activities, driving improvements, and ensuring ALCOA+ considerations are integrated into the fabric of how we operate.
- Identify, risk assess and remediate any deficiencies relating to the PQS.
- Participate in local and site-wide audits and inspections, acting as a Subject Matter Expert, where appropriate.
- Keep abreast of and maintain systems in line with changing regulations and industry expectations.

Support the Head of Compliance and Technical Quality in the execution of their duties, as required.

**Benefits**:

- Company pension
- Cycle to work scheme
- Employee discount
- Enhanced maternity leave
- Enhanced paternity leave
- Flexitime
- Free parking
- Life insurance
- On-site parking
- Private medical insurance
- Referral programme

Schedule:

- Day shift
- Flexitime
- Monday to Friday

Supplemental pay types:

- Bonus scheme
- Performance bonus

Ability to commute/relocate:

- Morpeth: reliably commute or plan to relocate before starting work (required)

Application deadline: 28/05/2023


  • Quality Systems Lead

    2 weeks ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    To lead a team that collectively, is responsible for administering and delivering the Pharmaceutical Quality System (PQS) across the Morpeth facility.Maintain and develop systems and processes that proactively keep the site ahead of the curve in changes to legislation, technology and risk-based approaches. Drive a quality culture within the business that...

  • IS Quality Analyst

    2 months ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    1 month ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    2 months ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • Director of Quality

    6 days ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    This role has accountability for the management of the Quality Operational functions at Piramal Pharma Solutions Morpeth Site.​ ​The role has responsibility for tactical and operational management of the Quality Assurance and Quality Control functions and is part of the Site Leadership Team.​ ​The role will maintain and develop the Quality Operations...

  • Director of Quality

    3 days ago


    Morpeth, United Kingdom Piramal Pharma Solutions Full time

    This role has accountability for the management of the Quality Operational functions at Piramal Pharma Solutions Morpeth Site.​Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. ​The role has responsibility for tactical and operational management of the Quality...


  • Morpeth, United Kingdom Northumberland County Council Full time

    In support of the Executive Director of Children, Young People and Education, the Director Children, Young People and Families (reporting to) and the Director of Education, SEN and Skills provide strategic direction of all the quality assurance for Childrens Services supporting the Councils key corporate and partnership priorities that fall within the remit...

  • IS Quality Analyst

    2 months ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    2 months ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...

  • IS Quality Analyst

    4 weeks ago


    Morpeth, Northumberland, United Kingdom Piramal Pharma Solutions Full time

    We are seeking an experienced IS Quality Lead to join our team. As the IS Quality Lead, you will be responsible for overseeing the implementation and maintenance of IT systems and processes in accordance with GMP regulations and guidelines. You will play a pivotal role in ensuring regulatory compliance, managing deviations and CAPAs, and leading validation...


  • Morpeth, United Kingdom MTrec Recruitment Full time

    **Rewards & Benefits on Offer;** - Permanent Contract. - Immediate Start Available. - Permanent Day Shift. - Progression Pathways. - Company Pension scheme - Discretionary bonus scheme (Gainshare/Christmas bonus). - On-site free parking - Life Assurance - Community volunteer programme - Social events **MTrec’s New Opportunity;** **The Job You’ll...