Tnp Trainee Regulatory Conformance Officer

Singapore, Singapore

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\xe2\x80\x99s 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 visitA certificate will be given to successful trainees upon completion of the programme.Role Description:To ensure corporate compliance of GlaxoSmithKline by providing accurate interpretation of Group standards, pharmacopoeial requirements and commitments made to regulatory authorities for application within Primary Supply (PS) for the manufacture of new and established bulk drug substancesTrainee to be involved in:Contribute to the development of regulatory strategies and manage the registration of new products, and facilitate regulatory approval without undue regulatory restriction of company operations.Interpret and provide advice on regulatory and compliance requirements for bulk drug substances to ensure that strategic decision-making fully embraces regulatory requirements and organisation standards without causing undue burden to the business.Support site change control, investigations and batch release, improvement initiatives through the provision of regulatory advice and act as an initiator or enabler for change implementation.Manage the regulatory submission process by ensuring timely supply of submission details from Primary Supply (PS) to achieve timely approval from regulatory authorities.Deliver authorised statutory documentation to regulatory authorities and manage the implementation of registered commitments to ensure continuous compliance with inspection requirements.Gather intelligence on new legislation and requirements, and provide specialist advice on the implication of legislation / requirements to the businessConduct expert reviews of information, facilities and practices used by the business and external parties to ensure implementation of required regulatory strategies and compliance with standards.Support external and internal audits.We are looking for you with below attributes:Candidate with an honours degree in a relevant science disciplineDemonstrate commitment to cGMP compliance aspects.Excellent self-motivated team player with good interpersonal, oral and written communication skillsAbility to understand, apply and evaluate basic cGMP principles.Where will I be based?You will be based at one of our manufacturing site in Singapore near Jurong.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 GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s 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 \xe2\x80\x93 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/ AgenciesGSK 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.

GlaxoSmithKline

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Job Detail

  • Job Id
    JD1445823
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned