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, X and YouTube.

Job Description

Purpose Statement: Senior Quality Operations Specialist must assist site management to oversight the quality system execution on the manufacturing and production areas at all times. Incumbent is required to observe, document, discuss, monitor and trend, and report quality adverse events related to the manufacturing of the product. 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.

Ensure that products manufactured at AbbVie Operations Singapore meet approved company policies, processes and procedures.
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.
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.
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.
Release incoming material, process, and product batches.
Responsible for Annual Product Quality Review and Product Quality Assurance.
Perform regular walk-thru of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times.
Responsible to perform data trending independently and champion improvement kaizen with respective areas for continuous improvement.
Proactively seek to improve and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
Lead and support quality system implementation as appropriate.
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.
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.
Participate and support new product introduction, operation excellence projects assigned by management as appropriate.

Qualifications

Bachelor Degree in a Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
This position requires knowledge of quality / compliance management as well as regulations
and standards affecting APIs / Biologics.
Minimum of 6+ years of pharmaceutical, biopharmaceutical experience in Quality and/or
Compliance (GxP) environment.
Experience in SAP, Trackwise are strongly preferred.
Application of quality risk management
Total commitment to quality and maintain a high standard of work at all times
Demonstrates the highest levels of integrity and a strong work ethic
Good knowledge of GxP requirements and regulations
Good project management, planning and scheduling skills
Good communication skills both verbal and written
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 and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://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

Recruitment Fraud Alert

We have recently become aware of various recruitment phishing scams targeting job seekers. Please be advised:

AbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.
If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.

If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.

Protect yourself by verifying job offers and communications. Your safety is important to us.

Where We Work

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.