QC Lead (Chemistry Analytical Methods)
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 recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.
GSK Vaccines has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in 160 countries, preventing a range of diseases such as; hepatitis, rotavirus and HPV infections, diphtheria, tetanus, whooping cough, measles, mumps, rubella, bacterial meningitis and influenza. Our Tuas site, one of only two GSK global vaccines manufacturing facilities worldwide, operates around-the-clock to manufacture the active ingredient used to make a GSK vaccine that protects children against pneumonia.
As the QC lead for chemistry ASAT processes, you are responsible to oversee the QC processes and oversight, perform development, validation/verification activities where required.
a) Manages team to assure adherence to team/ department/ site KPIs
b) Participates and supports GMP audits
c) Leads and manages department/site projects and initiatives with minimum guidance
d) Keeps up-to-date on the regulations/ development concerning biopharmaceutical QC activities (relevant to area of responsibiliy) to ensure quality control operations are in compliance to applicable corporate, regulatory and external agency regulations and guidelines
e) Supports the manager to ensure knowledge retention and effective training within team
f) Ensures all in-use procedures are current and compliant
g) Writes/ reviews/ approves required GMP documentations such as SOP, protocols, reports
h) Writes/ reviews/ approves notifications (events and deviations) and/or CAPAs
i) Writes/ reviews/ approves changes (CCs)
j) Leads/ manages investigation of non-conformities (events and deviations)
• Ensures thorough investigation and timely closure with effective CAPA to prevent recurrence
k) Provides guidance, support and technical expertise on quality control operations (relevant to area of responsibility) to ensure full compliance to applicable corporate, regulatory and external agency regulations
l) Manages local compendium system
m) Problem Identification and Solving :
• Identifies and reports problems in QC. Recommends and coordinates appropriate corrective actions to quality problems in conjunction with other departments. This includes managing non-conformities (lab and facility etc.), local CAPAs and leading investigations as necessary.
• Presents in a timely manner major issues to the management with strategies on their resolution.
Specific to job role
a) Provides technical expertise and consultation to testing teams on technical matters.
b) Lead/ manage projects
• Deliver timely implementation of projects with full compliance to corporate, regulatory and external agency regulations (as applicable)
• Manage and implement changes (CCs) required by testing team; including but not limited to new equipment, material and method introduction, and compendial updates
• Perform development/ validation/ verification activities (where required)
• Ensure methods/ knowledge are effectively transferred to routine testing team.
Key Responsibilities area:
1. GMP Compliance
2. Quality metric performances
3. Continuous improvement projects/ initatives
4. Leadership and interpersonal skills
5. Finanical metric performances
6. Safety metric performances
You are a passionate quality professional with the following attributes:
• University degree in a relevant science discipline
• At least 6 years of relevant working experience (includes supervisory experience) in pharmaceutical environment
• Preferably with laboratory experience (advantage)
• Competent technical skills in the followings :
• Common laboratory techniques (advantage)
• laboratory equipment qualification
• method validation
• computer system validation
• Knowledge of cGLP & cGMP
• Preferably with knowledge of statistics (advantage)
• Preferably with SAP knowledge (advantage)
• Preferably with knowledge of compendium (advantage)
• Effective report writing skills
• Planning and Organizing skills
• Good interpersonal and communication skills
• Effective team player
• Leadership skills
• Analytical skills with logical thinking
• Conflict management skills
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.
Closing date for applications: 31st Oct 2018
You may apply for this position online by selecting the Apply now button.
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