Senior Quality Operations Specialist

Abbvie; Southwest; On-site; SGD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Quality Operations Specialist to oversee quality system execution in manufacturing. This role involves ensuring compliance with company policies, leading investigations into non-compliance, and championing quality improvement projects. The ideal candidate will have a strong background in pharmaceutical quality and compliance, with a commitment to integrity and excellence. Join a dynamic team dedicated to transforming lives through innovative solutions and making a significant impact in the healthcare sector.

Qualifications

• 6+ years of pharmaceutical experience in Quality and Compliance.
• Strong knowledge of regulations affecting APIs/Biologics.

Responsibilities

• Ensure compliance of manufactured products with company policies.
• Lead investigations and root cause analysis for non-compliance.
• Perform regular audits and data trending for continuous improvement.

Skills

Quality Management

Compliance Management

Root Cause Analysis

Project Management

Communication Skills

Interpersonal Skills

Education

Bachelor Degree in Natural Sciences

Pharmacy Degree

Engineering Degree

Tools

SAP

Trackwise

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and Tik Tok.

Job Description

Purpose

The Senior Quality Operations Specialist assists site management to provide oversight on the quality system execution for the manufacturing and production areas at all times. The incumbent is required to observe, document, discuss, monitor and trend, and report quality adverse events related to the manufacturing of the product(s). Incumbent is required to lead and champion quality system improvement projects. QO Specialist is responsible to ensure highest quality and compliance of released batches at the AbbVie Operations Singapore, Tuas Singapore site.

Key Responsibilities

1. Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, processes and procedures.
2. Execute and provide oversight on procedures to ensure that incoming materials including raw materials and commodities received at ABS meet approved company policies and processes.
3. Lead and provide guidance in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing or product. Perform root cause analysis and identify effective corrective action and preventive action.
4. Perform audit or review of completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g. QA Hold, QA tag out.
5. Release incoming material, process, and product batches.
6. Responsible for Annual Product Quality Review and Product Quality Assurance.
7. Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
8. Responsible to perform data trending independently and champion improvement kaizen with respective areas for continuous improvement.
9. Proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
10. Lead and support quality system implementation as appropriate.
11. Lead and act as Subject Matter Expert in change management. Activities including to lead/participate in cross functional team risk assessment and provide guidance in change management process.
12. Primary contact as site change coordinator and liaison with global change coordinator to ensure all the global change proposal is managed and administrated in accordingly to the procedure.
13. Participate and support new product introduction, operation excellence projects assigned by management as appropriate.

Qualifications

1. Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering
2. 6+ years of related pharmaceutical experience, with biopharmaceutical experience in Quality and / or Compliance (GxP) environment
3. Strong knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics
4. Experience in SAP, Trackwise strongly preferred
5. Total commitment to quality and application of quality risk management
6. Demonstrates the highest levels of integrity and a strong work ethic
7. Good knowledge of GxP requirements and regulations
8. Good project management, planning and scheduling skills
9. Good communication skills both verbal and written
10. Good interpersonal skills and able to work with cross functional team collaboratively

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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