GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies.
We are proud of the difference we make. GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its 'Change the World list' which recognizes companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.
As a Compliance officer, you will have the accountability to ensure that quality compliance standards are defined, established and maintained on site in accordance with both internal (corporate) and external regulatory expectations on current Good Manufacturing Practices (cGMP)
You will also be responsible for:
•Establish/maintain quality compliance standards consistent with QMS by providing support in areas such as
◦Reviewing site policies, procedures and training materials related to quality system
◦Providing advisory support to business on compliance area
• Manage all the quality related risks in Quality Department, including identification, escalation, documentation in Risk Management System (RMS) and monitoring of progress of mitigation plans and action plans.
• Manage inputs for Quality Risk Model for governance reporting
•Manage quality related Key Performance Indicator (KPI), including data collation, regular KPI metrics reporting and identification of issues and opportunities for improvements in site quality performance.
•Conduct internal audits to ensure QMS requirements are In-Place and In-Use.
•Support both internal (GSK corporate) and external inspections in preparation to assure cGMP compliance
•Ensure the effective implementation of the GMS standard training
•Lead and/or support Data Integrity Gap Closure and Risk Mitigation activities.
•Manage GxP service providers to ensure they are qualified and periodically re-qualified to meet GSK requirements.
•Provide surge support for documentation control throughout the document lifecycle.
•Support or function as site liaison for Regulatory Intelligence and act as Subject Matter Expert for the interpretation and provision of advice on regulatory and compliance requirements.
•Steer and/or implement
◦standardization of quality systems across key quality systems
◦Quality improvement projects
In return, we offer the opportunity to further enhance your analytical skills in a world class pharmaceutical organization.
GSK's dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply.
Please note that this is a 12 month contract, renewable.
Closing date for application: 1st Dec 2018
Ideally, you should be someone with:
•At least an honors degree in a relevant science discipline
•At least 5 to 8 years of relevant experience in the pharmaceutical industry for the Senior Compliance Officer and at least 3 years of relevant experience for Compliance Officer
•Preferably with experience in GMP training.
•Extensive knowledge of GMP
•Extensive knowledge of quality and manufacturing processes
•Good knowledge of corporate quality management systems
•Good knowledge of quality and manufacturing process
•Good interpersonal and influential skills
•Good oral and written communication skills
•Adherence to schedules.
• Sound knowledge and on-going awareness of regulatory requirements (includes safety)
• Good communication skills
• Knowledge of business process within GSK
• People management skills
GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years.
To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.
You may apply for this position online by selecting the Apply now button.
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.
Back to top