Total 3 service operations manager job vacancies in Quality Assurance / Control category in Singapore

Purpose

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.

Responsibilities

• 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.

Qualification and experience

Qualifications

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.

Experience

• 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.

Skills

• Application of quality risk management.
• Total commitment to quality and maintain a high standard of work at all times.
• Demonstrates the highest level 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.

Purpose

To provide an effective testing and analytical service to the plant ensuring that products manufactured are tested to specification on time and plant quality and safety goals are met. Ensure that all raw material, in-process and finished product testing and method transfer testing is carried out per schedule and per GMP. Ensure that records are maintained to appropriate requirements.

• Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures.
• Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath and etc.
• Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management.
• Review lot release data, identify testing discrepancies and participate in laboratory investigations.
• Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness.
• To assist in writing SOP documents, Change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design.
• To carry out completion and review of GMP Documentation of data sheets or LIMS software.
• To carry out QC sample receipt, assay and release procedures.
• Support Audit preparation and any audit related activity.
• Reading and understanding the test procedure and the requirements per USP, JP and EP.
• Require to perform 12 hours shift work.

Qualification and experience

• Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree.
• More than 2 years relevant experience, preferably in the bio-pharmaceutical / Pharmaceutical industry.
• Good working knowledge of cGMP and regulatory requirements related to Quality is preferred.
• Problem-solving and troubleshooting skills.
• Highly motivated and independent.
• Possess good interpersonal and communication skills.
• Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance’s and industry standards for analytical development and characterization.

Job Responsibilities

• Responsible for the organization, administration, training, development, and supervision of personnel under QA Documentation and Training Area. The incumbent hires, trains, develops, evaluates performance, and administers following established personnel policies and procedures.
• Maintains an organizational structure capable of meeting both the immediate and long term objectives of the Quality areas under his/her responsibility. 
• Prepares annual/update budgets for the sub department.  Responsible for developing, implementing and maintaining the effectiveness of the quality system (Quality Documentation, Training and Supplier Quality departments).
• Owner of the Management Review process and related metrics tracking and trending. (Quality Documentation, Training and Supplier Quality departments)
• Ensure compliance with applicable AbbVie policies, processes and procedures, contributing to the development of strategies and oversight of complex programs.
• Drive implementation of policies and procedures to maintain compliance to global regulatory requirements for policies, processes, and procedures.
• Manage broad and cross-functional quality programs, initiatives and organizational change related to the AbbVie quality system.
• Lead goals with cross-functional/cross-divisional/global scope.
• Ability to expedite and resolve issues. Elevate issues as appropriate.
• Responsible for Training Section and for the establishment, administration, and maintenance of a CGMP training program.
• Responsible for Documentation Section and for administration and maintenance of documentation control quality programs such as: Document Change Control, Document Retention, and Batch Record Archive, among others. 
• Responsible for Supplier Quality Section and for the establishment, administration, and maintenance of a supplier quality programs such as CAPA system oversight, Supplier Quality Management and Supplier Qualification. 
• Operates within the constraints of limited human and financial resources and changing priorities.  Liaison with other AbbVie Sites and 3rd Parties. 
• Participate fully and/or chair relevant Project team meetings. 
• Actively supports functional work centers within Quality and Site to achieve goals. – QC, Engineering, Quality Systems and Operations.
• Assists Quality Director with assigned tasks including budgetary control and key meeting preparations.

Requirements

• Degree or Higher in Science or Engineering discipline. 
• Quality or Regulatory Qualification an advantage but not essential. 
• A minimum of 5 years’ experience in a Quality or Project/ Program Leadership role in pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment 
• Strong communication skills, written and oral.
• Excellent knowledge of pharmaceutical regulatory requirements (GMP) is essential. 
• Previous Leadership experience essential, 2 years min in either Project leadership or people leadership roles.
• Demonstrated change agent and innovative person. 
• PMP software skills an advantage. – MS Project, Mind Manager etc.
• Requires knowledge of quality/compliance management as well as regulations and standards affecting APIs and Biologics
• Experience in managing diverse teams is preferred.
• Expected to demonstrate high levels of integrity and a strong work ethic at all times and ability to supervise a team including supervisors, contractors and trainees
• Strong problem solving skills and highly independent
• Self driven and meticulous individual