Senior Manufacturing Specialist

AbbVie Inc.; Singapore; Presencial; SGD 120.000 - 180.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a seasoned professional to manage technical documentation and drive continuous improvement in a biologics manufacturing context in Singapore. You will investigate non-conformances, implement CAPAs, and collaborate with Operations and quality to ensure GMP compliance.

The role includes developing training modules, managing change control, and supporting regulatory inspections, with emphasis on data integrity and effective communication across cross-functional teams.

Formación

• Master or degree with 5–7 years in Biologics Production or equivalent.
• Good working knowledge of cGMP and regulatory requirements for manufacturing.
• Experience with GMP systems such as Trackwise, SAP, LIMS, MES preferred.
• Experience with regulatory inspections is required.

Responsabilidades

• Perform technical writing and investigate non-conformances with Operations and cross-functional teams.
• Develop and implement corrective and preventive actions with Operations.
• Lead change processes to enhance operations and document updates.
• Create and conduct training modules for Operations and new hires.
• Analyze KPIs and optimize workflows; manage electronic batch records.
• Support regulatory inspections and internal audits; engage in improvement projects.
• Organize regular cross-functional meetings to discuss daily operations.

Conocimientos

Technical writing

GMP compliance

Change management

Cross-functional lead

Gemba walkdowns

Regulatory inspections

Quality systems

Trackwise

LIMS

SAP

Educación

Master's or degree (Biologics/related)

Herramientas

Trackwise

LIMS

SAP

POMSnet

Delta-V

MES systems

Descripción del empleo

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube.

Job Description

Purpose Statement

• Ensure operational efficiency and compliance by managing technical documentation, addressingnon-conformances, and implementing corrective actions.
• Streamline processes and drive continuous improvement across manufacturing operations.
• Effective change management, thereby fostering process enhancements and ensuring compliancewith regulatory standards.

Operations and Technical

• Conduct technical writing and collaborate with Operations and cross-functional team to investigate non-conformance issues.
• Develop and implement corrective and preventive measures together with the Operations team and cross-functional team.
• Manage change processes to enhance operations.
• Develop and conduct training modules for Operations and new employee onboarding.
• Analyze key performance indicators and execute strategies to optimize workflows.
• Author and revise GMP-related documents.
• Collaborate on the creation, revision, and enhancement of electronic batch records.
• Lead or participate in projects aimed at enhancing operations or new product introduction.
• Utilize quality management systems and operations-related software, such as Trackwise, LIMS, SAP, POMSnet, Delta-V or others.
• Prepare and support regulatory inspections and internal audit.
• Engage in projects aimed at continuous operational improvement.
• Engage in regular GEMBA walkdowns.
• Organize regular meetings with cross-functional teams to discuss and update daily operational matters.

Safety

• Ensures a safe work environment by adhering to regulatory and global/local Environmental, Health, and Safety (EHS) policies.

Quality

• Ensure investigations are conducted and completed promptly and to a high standard.
• Ensure that process improvements are relevant and beneficial to the manufacturing operations.
• Verify the accuracy of impact assessments and ensure corrective and preventive actions are relevant.
• Serve as point of contact for change management documentation and investigations during audits and inspections.

Schedule

• Strive to complete investigations in a timely manner to minimize any potential impact on batch release timelines or shipment schedules.
• Ensure that process improvement changes are executed on schedule as planned for the production run.

Qualifications

• Master or Degree with at least 5-7 years relevant experience in Biologics Production facility, or
  equivalent.
• Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred.
• Strong working knowledge of GMP systems such as Trackwise, SAP, LIMS, MES systems are preferred.
• Experience with cGMP documentation and record maintenance.
• Experience with Regulatory inspections is required.
• Strong ability to lead and drive cross-functional teams.
• Possesses a positive work attitude and a strong determination to complete tasks efficiently.
• Agility, capable of performing under pressure, and able to address various priorities.
• Good presentation and strong technical writing skills.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html