Senior Manufacturing Specialist

AbbVie; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

AbbVie in Singapore is seeking a skilled professional to ensure operational efficiency by managing technical documentation, addressing non-conformances, and implementing corrective actions. You will streamline processes and drive continuous improvement across manufacturing operations while maintaining compliance with regulatory standards.

Responsibilities include leading change management, developing training modules, and collaborating on quality systems such as Trackwise, LIMS, and SAP.

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.
• Posssesses 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.

Responsibilities

• Manage technical documentation and investigate non-conformances.
• Develop and implement corrective and preventive actions with Ops and cross-functional teams.
• Lead change processes to enhance operations and support trainings.
• Collaborate on electronic batch records creation, revision and improvement.
• Prepare for regulatory inspections and internal audits.
• Engage in continuous operational improvement and regular GEMBA walkdowns.

Skills

Technical writing

Cross-functional collaboration

Leadership

Agility under pressure

Education

Master's degree in Biologics Production

Tools

Trackwise

LIMS

SAP

POMSnet

Delta-V

MES systems

Job description

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 , X and 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.