Tuas, North Carolina, Singapore
7 days ago
TnP Trainee - QC Specialist (ASAT)
Site Name: Singapore - Tuas Posted Date: Apr 9 2024 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. For more information, please visit Career Conversion Programmes (CCP) for Individuals A certificate will be given to successful trainees upon completion of the programme. Purpose: To provide technical support to routine testing teams in the frame of the Analytical Science and Technology (ASAT) team around method development/ qualification/ validation/ verification and equipment qualification Key Responsibilities: Technical responsibilities Manages and implement method development/ qualification/ validation/ verification and equipment qualification required by routine testing team, including but not limited to new equipment, material and method introduction and compendial updates Keeps up-to-date on regulations/ development of biopharmaceutical QC activities to ensure QC operations are in compliance to applicable corporate, regulatory and external agency regulations Leads/ manages investigation of non-conformities (events and deviations) and complex tasks (e.g. continuous improvements, department/ site projects and initiatives) Knowledge management on knowledge retention and effective training to ensure methods/ knowledge are effectively transferred to routine testing team Writes/ reviews change controls, events/ deviations, CAPAs and GMP documents (e.g. SOP, protocols, reports) Provides technical expertise and consultation to routine testing team on technical matters to ensure compliance to applicable corporate, regulatory and external agency regulations Subject-Matter-Expert (SME) audit fronter for assigned topics Supports local compendium system Performs review of compendium updates timely and accurately. Supports investigation system in QC Performs trends for invalids, atypical results and OOS Problem Identification and Solving: Identifies and reports problems in QC. Recommends and coordinates a ro riate corrective actions as necessary Organization and Management Responsibilities Works with senior specialists/ chemists and manager to create a culture of accountability, ownership and continuous improvement Respects all safety and security polices, laboratory policies and practices on site Ensures expenditures are within budget Works across boundaries across departments and/or sites Works with senior specialists/ chemists and manager to align the priorities of the team with those of the department Able to work independently, shows initiative and able to work with all levels of staff Provides adequate guidance and technical support to other team when necessary Decision Making Proposals & Recommendations Based on experience & knowledge of work Proposal of CAPA for any issues/ deviations/ exceptions/ risks Proposal of QC improvement projects and strategies Team training and development Skills: Professional University degree in a relevant Science discipline with at least 2 years of working experience or Diploma with at least 5 years of working experience Technical Competent technical skills in the followings: Common laboratory techniques (advantage) Laboratory equipment qualification (advantage) Method validation (advantage) Computer system validation Knowledge of cGLP & cGMP Preferably with knowledge of statistics (advantage) Preferably with knowledge of compendium (advantage) Preferably with knowledge of QC laboratory investigation (advantage) Business Effective report writing skills Planning and Organizing skills Good interpersonal and communication skills Effective team player Analytical skills with logical thinking Problem solving skills Competencies: Good command of English Good knowledge of Microsoft office Attributes required of the job e.g. the ability to work independently; the ability to work in a team; shows initiative; able to work with all levels of staff Competencies must consider the key responsibilities, scope of accountabilities and required experience Where will I be based? You will be based at one of our manufacturing site in Singapore near Tuas. How can I apply? Applications are now open. Click on the button above to apply. We recommend you apply as soon as possible, because we accept ongoing applications and offer positions on a first come, first served basis! At GSK we value diversity and treat all candidates equally. We strive to make our recruitment process free of bias of any kind and aim to create an inclusive workplace at GSK. If you require any assistance, either to attend an interview or during the course of the recruitment process, please let us know. Why Us? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
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