QA Validation Specialist

2 weeks ago

Tuas, Singapore GSK Full time

**Site Name**: Singapore - Tuas
**Posted Date**: Oct 16 2024
**_ Purpose:_**:

- To lead and manage Site validation activities (as assigned) to ensure that validations are in compliance with company procedures, regulatory requirements, and cGMP expectations.
- To provide QA compliance oversight over IT and Technical Services (as assigned)

**_
Responsibilities:_**:
1. Ensure site validation activities are compliant with Site procedures, regulatory requirements, and cGMP expectations
- Author and maintain the quality system SOPs for validation.
- Define validation approach that is technically sound and are compliant.
- Author Validation Plans and Reports, including Continuous Validation Plan
- Review and approve validation deliverables
- Provide solutions to achieve validation requirements
- Collaborate with Operations to define the validation schedule and support the timely completion of activities as per schedule
- Drive efficiency, improvement and robustness in site validation systems and processes
- Be the link with Global Validation for technical information, and standards roll out
- Assess impact to validation and validation status during change management, and define appropriate validation requirements and approach to maintain validated status of systems
- Assess impact to validation for incidents/deviations and ensure appropriate CAPAs are in-place to resolve issues and prevent recurrence
- Perform Periodic Review and prepare the review report for systems and processes
- Oversee Periodic requalification and Continued process verification to maintain the validated status of systems and processes
- Conduct GSK internal audits and front as SME in external regulatory inspections
- Provide support for all activities related to GPS (e.g. Tiers, Gemba, DMAIC etc) for continuous improvement

2. Provide QA Oversight to IT operations in areas of:

- QA consultation to review and approve SOPs
- Review and approve changes, deviations and CAPAs

3. Provide QA compliance oversight to Technical Services
- Interact with TS personnel in day-to-day operations to ensure cGMP compliance
- Be the QA approver for TS activities including but not limited to:

- LSOPs, Deviation/Event, CAPAs, Change Controls,
- Quality Tag-Outs
- Calibration & maintenance programmes
- Pest control reports

4. Interface with Internal & External stakeholders
- Effective interfaces with internal and external stakeholders to ensure effective communication with and cascades from Global functions

5. EHS
- Comply with company requirements on EHS

**_ Knowledge, Skills, and Experience:_**:
**Professional**
- At least University basic degree in a Science or Engineering discipline
- At least 2 years' experience in pharmaceutical industry or related regulatory fields
- At least 5 years for Senior QA Validation Specialist role

**Technical**
- A good understanding of cGMP regulatory and legal requirements as applied to quality assurance and validation of pharmaceutical manufacturing
- Good understanding of regulatory inspection requirement
- A good working knowledge of validation, preferably with hands-on experience
- Computer skills in MS Office and familiar with web-based e-learning resources
- Potential or developing project management skills

**Business**
- Ability to facilitate business activities compatible to international regulatory environment
- Ability to communicate effectively within site organization and across network
- Potential or developing planning and organizational skills

Li-GSK

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Important notice to Employment businesses/ Agencies

  • QA Specialist

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    : We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the testing, approval and release...

  • Senior QA Specialist

    1 week ago

    Tuas, Singapore Pfizer Full time

    QA Specialist (QC Support): - We are looking for individual who can work independently, have good interpersonal skill and good laboratory compliance. The incumbent will have the responsibility for QA operational oversight for the site Quality Control (QC) and ensures overall quality integrity of the chemical and microbiological laboratories to support the...

  • Specialist 1, QA

    2 weeks ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • Specialist 3, Validation and Technical Compliance, QA

    1 week ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • QA Specialist

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    ***: - Drive quality culture and promote GMP compliance behaviours to the site. - Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines. - Provide oversight to the site GMP operations to ensure products produced in compliance with the Pfizer Quality Standards (PQS). - Collaborate with cross functional teams to improve quality...

  • QA Specialist 3, Operations

    1 day ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • Specialist 1, QA

    2 weeks ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • QA Specialist Label Design

    1 week ago

    Tuas, Singapore Superform Consulting Pte Ltd Full time

    Job Title: QA Specialist Label Design **Salary**: Up to $4000 Location: Tuas Working Days: Monday - Friday Working Hours: 7.45 am to 4.55 pm **Responsibilities**: - Work with the graphics and translation to create artwork, drawings, and associated documentation for labeling. - Ensure that labeling artwork and proofs are accurate and meet all medical...

  • Specialist 1, QA

    2 weeks ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas Singapore Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • QA Supervisor

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Specialist 3, QA

    6 days ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Senior QA Manager

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    The incumbent will be required to develop strategic and system action plans by conducting risk assessment, identifying critical control points and preventive measures, establishing critical limits, monitoring procedures, corrective actions, and verification procedures. The incumbent will ensure that the quality systems, the products manufactured and Good...

  • Senior Specialist Ii, QA Cell Therapy

    1 week ago

    Tuas, Singapore Lonza Full time

    Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers....

  • Specialist 3, QA

    1 week ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • Senior Quality Engineer

    1 week ago

    Tuas, Singapore BD Singapore Full time

    Job Description Summary **Job Description**: We are the makers of possible BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of...

  • Specialist 2, QA

    2 weeks ago

    Tuas, Singapore Lonza Full time

    Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their...

  • QA Specialist

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    The incumbent will establish, maintain, coordinate and support the Quality Systems Compliance such as Change Control, Deviation, Internal Audits, Regulatory Inspections and GMP Training to support the various business processes on site in full compliance with GMP predicate rules, regulatory requirements and Pfizer’s internal requirements. Review and...

  • QA Specialist

    6 days ago

    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...

  • Qualityteamleader,qa Ops-mfg Mgt(QA Sf)

    2 weeks ago

    Tuas, Singapore Novartis Full time

    **Summary**: Responsible for operational leadership of a defined area within the site’s QA Operations unit. Ensure compliance with all cGxP, regulatory and HSE aspects as well as responsible for people leadership within are of responsibility. **About the Role**: **Quality Team Leader, QA Ops-Mfg Mgt (QA SF)** **About the Role**: Responsible for...

  • QA Supervisor

    2 weeks ago

    Tuas, Singapore Pfizer Full time

    Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...