Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.

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

Sunningdale Tech Ltd is a leading manufacturer of precision plastic components. The Group provides one-stop, turnkey plastic solutions, with capabilities ranging from product & mould designs, mould fabrication, injection moulding, complementary finishings, through to the precision assembly of complete products.

Boasting a total factory space of more than 4 million sq feet, with more than 1,000 injection moulding machines and a tooling capacity of 2,000 moulds per year, Sunningdale Tech is focusing on serving four key business segments – Automotive/Aerospace, Consumer/IT, Healthcare and Tooling.

With manufacturing facilities across Singapore, Malaysia (Johor, Penang), China (Tianjin, Shanghai, Suzhou, Zhongshan, Guangzhou, and Chuzhou), Latvia (Riga), Mexico (Guadalajara), North America (Phoenix), India (Chennai), Thailand (Rayong), and Indonesia (Batam), Sunningdale Tech is strategically positioned to target and capture opportunities in diverse business sectors globally.

As an industry leader with deep engineering expertise and experience, Sunningdale Tech is driven to solve your challenges by applying our advanced capabilities & leading technology in ways that benefit you. We’re ready to provide solutions at every step of the process to reduce lead time and add value for customers, while maintaining our excellent quality. Beyond that, we build on our strong foundations to think out of the box and apply relevant new possibilities for your complex engineering problems. Customers can trust us to constantly solve challenges to meet their needs, and apply new ideas for better outcomes.

Responsibilities:

• Resolves customer inquiries, quality, and operational issues in a timely manner by consulting with the Business Development HOD, Operation Manager, QA Manager, other supporting managers, Superior
• Manage, lead, and motivate a team of quality inspectors and technicians to meet departmental objectives and goals, create and promote food safety, GDP, GMP & lead by example
• Early involvement in new product and project development to establish internal specification and keep abreast of customer requirements
• Document in STL’s quality system and implement programs to ensure compliance with applicable regulatory requirements and corporate’s quality system requirements
• Develop and continually improve production, inspection and process control activities, corrective & preventive action, hazard analysis and risk management
• Responsible for timely closure of CAPA, non-conformance investigation report, customer complaints and deviations. Escalate to superior if required
• Analyse and trend various Key Performance Indicators per management’s vision and direction, including indicator of interest
• Develop, reviews, and approves qualifications and validation protocols, involvement in food Hazard/Medical device Risk management activities and departmental level risk and opportunity assessment, including JSA
• Ensures effective communication internally & externally
• Ensure department’s personnel competency, develop, and retain skill base knowledge within the organisation, through training needs identification
• Any other duties as and when assigned
• Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Requirements:

• Diploma and / or Bachelor Degree in Biomedical Engineering
• Minimum 2 year's experience in QA function, preferably in plastic injection molding company
• Strong knowledge of Quality tools and Quality concept fundamentals
• Ability to perform root cause analysis, process optimization, data analysis and validation effectively manage a high-volume manufacturing setting/environment
• Ability to apply problem solving technique and provide solutions under minimal supervision.
• Good written and oral communication skills
• Training and developing both technical and non-technical employees
• Prior supervisor experience managing several direct reports

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Only shortlisted candidates will be notified

Sunningdale Tech is an equal opportunity employer – we believe that a diverse and inclusive workforce will cultivate a vibrant, productive and innovative workplace where all employees are truly respected and valued.

All qualified applicants shall be considered for employment regardless of age, race, gender, gender identity, religion, marital status, medical condition, mental or physical disability, national origin, political and/or third party affiliation or veteran status. All offers of employment shall be conditioned upon successful completion of background checks, valid work passes and medical screenings, as applicable and/or mandated by law, and subject to the applicable local laws and regulations.

Job Responsibilities:

• Support continuous improvement efforts in QMS.
• Support in root cause analysis and implementation of corrective/ preventive actions for process related concerns.
• Analyze and provide timely respond to customer complaints.
• Interface with Customer and Operations to ensure new product transfer to manufacturing are in accordance with approved requirements.
• Prepare Quality performance metrics and reports.

Requirements:

• Diploma in Mechanical Engineering, Quality, or equivalent.
• Minimum 2 years work experience in Quality Management System in manufacturing environment.
• Good knowledge of ISO 9001. Knowledge of API Q1 is preferred.
• Strong command of English language, both oral & writing.
• Knowledge of metal working industry is preferred.
• Knowledge of risk assessment principles and methods.
• Knowledge of SAP is preferred.
• Positive & proactive attitude.