Current jobs related to Section Manager, QA - Tuas - Lonza

  • Section Manager, 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...

  • Section Manager, QA

    1 week ago

    Tuas, Singapore Lonza Full time

    Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there is 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...

  • QA Technician #64802

    7 days ago

    Tuas, Singapore Anradus Pte Ltd Full time

    Industry/ Organization Type: Manufacturing/ Chemical - Position Title**:QA Technician**: - Working Location: Tuas - Working Hours: Mon - Fri, 8.30 AM - 5.30 PM (shift work/ alternating timing if necessary) - Salary Package**:Up to $2,600 + AWS + Mobile Allowance**: - Duration: Permanent **Key Responsibilities** - Carries out all laboratory tests and...

  • Intern, Qo, QA-systems

    3 days ago

    Tuas, Singapore Pfizer Full time

    Internship Scope (Duties & Responsibilities) - Work with different teams within Quality and other departments to support Change Control and Deviation. - Support QA section on documentation and other functions. - Recognize different functions and operations of each QA team. - Carry out adhoc projects and assignments to support department goals. - Deliver CI...

  • QA Structural Supervisor

    2 weeks ago

    Tuas, Singapore Kuok (Singapore) Limited Full time

    **This position is for PaxOcean Group, a company under Kuok (Singapore) Limited.** **Position Summary** - Ensure that all inspections comply with construction standards, approved procedures and drawings, client specifications, as well as class rules, codes, and regulations (AWS D1.1) - Serve as the primary contact and advocate for the PaxOcean Quality...

  • Section Lead, Qc

    7 days 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...

  • Lab Admin

    1 week ago

    Tuas, Singapore The Supreme HR Full time

    **Job Scope**: 1. Involves in general laboratory administration along with Managers and Section Heads 2. Take charge of registration of test samples 3. Involved in sample labelling and assignment of jobs to different Analysts 4. Job handling and coordination with various Sections / teams 5. Assist QA Manager in Internal Audit and QA/QC tasks 6. Assist...

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

    5 days 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 Manager

    2 weeks ago

    Tuas, Singapore MacDermid Alpha Electronic Solutions Full time

    **Challenge Yourself and Impact the Future!**: MacDermid Alpha Electronics Solutions, a business of Element Solutions Inc (NYSE:ESI), is renowned worldwide for its commitment to revolutionizing the electronics industry. With a legacy spanning over a century, we have continually set new benchmarks for excellence, reliability, and sustainability in electronic...

  • Section Lead, Logistics

    1 week ago

    Tuas, Singapore Lonza Full time

    **Singapore, Tuas Singapore** Lonza is the pioneer and world leader in the CDMO industry operating across 5 continents, setting the pace with cutting-edge science, smart technology and lean manufacturing. We turn our customers’ break-through innovations into viable therapies and manufacture the medicines of tomorrow.At the heart of every scientific...

Section Manager, QA

3 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, genuinely improve the world. And that’s the kind of work we want to be part of.

Did you know that we are the 1st biologics contract manufacturer in Singapore ? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience - we, in Singapore are proud to be part of this global network.

The QA (Quality Assurance) Section Manager Validation is responsible to ensure all critical GMP (Good Manufacturing Practice) equipment and systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The role will support the Site & our internal stakeholders, and regulatory bodies with scientifically sound, documented evidence that our systems, equipment and processes will perform as required so they can be assured of a quality, compliant manufacturing environment.

**Key responsibilities**:

- Provide team oversight and planning of day-to-day Validation activities in accordance with approved Validation SOPS/ Plans/Policies for a large scale, multi-product, GMP biotech contract manufacturing facility including QC and Development Services.
- Participate in review and approval of Validation Sops I Plans I Protocols I Reports including site discrepancies and deviations investigation closure
- Ensure implementation of Site Validation Maintenance Program and re-Validation requirements are performed in accordance with approved Site Policies I Plans I Sops
- Monitor periodic reviews on trend analysis data for facility operating systems; identify issues and gaps, improvement strategies & generation of validation review reports
- Develop strategy for performing and managing the validation programs to assure that the validation activities are scheduled and performed as needed
- Perform & document detailed evaluation on critical validation processes and/or studies, including justification / rationale for approach, methodology, acceptance criteria and impact to product quality
- Ensure proper implementation of Validation requirements in accordance with Site GMP Policy
- Manage internal and external QA validation resources deployment to achieve department/ project goals
- Lead / Participate in Regulatory Inspection / Customer Audits and provides QA support for responses to all validation related queries as needed
- Development/ implementation of departmental Plans / Policies
- Leadership/managerial responsibilities for direct reports: examples include, provide leadership to subordinates by directing, mentoring, coaching and developing them towards personal growth, enhanced job performance and career satisfaction
- Support the analysis, and recommendation of solutions to process engineering challenges tied to Validation compliance and/or Facilities, Utilities, Equipment
- Any other tasks as and when assigned by the superior.

**Key requirements**:

- Degree or higher from recognized institution with extensive years of experience in Validation / Quality unit in the pharmaceutical/biotech industry
- Good knowledge and experience of the practical and theoretical requirement of validation program including Data Integrity in GMP facility
- Good understanding of validation principles and practices and a risk based approach
- Good appreciation of cGMP in biopharmaceutical manufacturing
- Experience with pharmaceutical Quality Systems including change control, deviation and CAPA
- Familiarity with Regulatory requirements and local Codes & Standards (e.g. ISPE, FDA, EMEA, and ICHQ7)
- Good leadership and interpersonal skills
- Good communicator, able to articulate complex information concisely and with sensitivity to the audience at hand and to build effective relationships with internal customers and supporting functions such as QC, QA, Engineering and Operations
- Exhibit good quality decision making traits
- Meticulous and Systematic, operational excellence ( ideally Yellow Belt or Green Belt Lean experience )
- Team player, with strong focus on safety, quality and timeline Analytical Mindset.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any succes