Career Conversion Programme - Quality Validation Officer

GLAXO WELLCOME MANUFACTURING PTE LTD; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A biopharmaceutical manufacturing company in Singapore is seeking a Trainee for Advanced Biopharmaceuticals Manufacturing. This role focuses on ensuring products meet compliance with Good Manufacturing Practices (cGMP) and regulatory standards. Responsibilities include reviewing validation processes and engaging in quality decision-making. Candidates should hold a degree in Chemical Engineering or related fields. This program is geared towards Singapore Citizens and Residents, offering a valuable pathway into the industry.

Qualifications

• Degree in Chemical Engineering, Chemistry or related fields.
• Ability to engage stakeholders, customers, and suppliers professionally.

Responsibilities

• Ensure products comply with cGMP and regulatory requirements.
• Draft and review policies and procedures for validation activities.
• Conduct validation reviews on a periodic basis.
• Approve changes impacting product quality and regulatory compliance.

Skills

Logical thinking

Oral communication

Written communication

Stakeholder engagement

Knowledge of GMP

Understanding of regulatory processes

Education

Degree in Chemical Engineering or related fields

Job description

The Career Conversion Programme (CCP) (Train-and-Place with Commitment to Hire) for Advanced Biopharmaceuticals Manufacturing Executives/Professionals is a talent development programme aimed at building the next generation of skilled manpower for Singapore’s Biopharmaceuticals manufacturing industry in anticipation of hiring demand.

The training programme consists of 15 months of local attachment with GSK. Due to the nature of the programme, we can only consider Singapore Citizens and Singapore Permanent Residents. Due to the nature of this traineeship programme, kindly note that training allowances are CPF exempted.

For more information, please visit Career Conversion Programmes (CCP) for Individuals

Role Description

This position reports to the Technical, Quality & Validation Manager and supports key quality operations at the site.

Trainee to be involved in

To ensure that products manufactured are in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements so as to meet stipulated product quality standards in line with the established specifications of the organization.

• Draft, compile, review and update appropriate policies and procedures in support of the validation activities on site
• Assess, review and approve changes that may have an impact on the product quality, regulatory and validation status of the facility, processes, method validation or systems on site
• Ensure that validation review of systems or processes are conducted on a periodic basis to ensure that the validation status is maintained, make recommendations for re-validation as required, pending outcome of the validation review, and approve Continued Process Verification (CPV) documents
• Assess, review and approve changes that may have an impact on product quality, validation and/or cGMP compliance. Upon implementation of changes, review and ensure proper closure of changes

Education / Licenses

• Degree in Chemical Engineering, Chemistry or related fields

Competencies / Skills

• Develop logical thinking skills through active participation in change controls and quality decisions made
• Develop oral and written communication skills
• Engaging stakeholders, customers and suppliers professionally
• Gain experience with online system used for change controls
• Gain extensive knowledge on GMP, validation, quality and manufacturing processes
• Gain understanding of regulatory processes
• Gain exposure to internal audits (as auditee)

Where will I be based?

You will be based at one of our manufacturing site in Singapore near Jurong.

Apply to the role: https://jobs.gsk.com/en-gb/jobs/428003?