GlaxoSmithKline Quality Specialist, Pharmacist in United States
In GSK Consumer Healthcare, we are on an incredible journey as we prepare to create a new, standalone, world leading company with a 100% single-minded focus on everyday health. We are doing this at a time when the work we do has never mattered more. With the COVID pandemic, people are increasingly looking for ways to manage their own health and wellbeing and to take care of their families. This is where we come in. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we are uniquely placed to deliver better everyday health to millions of people around the world and grow a strong, successful business. This is an opportunity to be part of something special.
Quality Specialist, Pharmacist
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Handling quality complaints, registering them in the system, prioritizing, contacting with factories, explaining complaints, and resolving them. Sending complaint samples. Creating local procedures for the handling quality complaints.
Coordination Consumer Healthcare documentation , adding new documentation, handling SOP Index Tracker, giving opinions, archiving checking and approving Standard Operating Procedures and Working Instruction.
Support LOC NPI process through the Change Management Process and GMM codes management
Provide support to LOC QMS activities in activities that maintain/develop the LOC Quality Management System and develop the Quality culture such as implementation of Quality Modules.
Administrative support for local Training/ on-boarding activities, creating training matrix, coordination preparing Job Description by LOC Team
Local Repacking: Support Quality Manager in all matters pertaining to GxP, Regulatory and & QMS compliance for repacking procedures to ensure timely QA approval before initiate any re-packing activity for MDD products
Supporting Quality Manager in preparing and handling Quality Agreements and TTS
Participate in investigation of complaints, deviations, and product incidents and recalls ensuring that all investigations are thorough, complete, identify root cause, and assign appropriate CAPAs and is accountable for team metrics ensure effective liaison with LOC third party and other business partners on quality related topics.
Support Responsible Person (GDP) the ‘GDP administrative release’ process of RP-released batches of medicinal products, , including monitoring and evaluation of Batch Release processes.
Support and/or perform Independent Business Monitoring (IBM) and Self-Inspections (SI), in full compliance with GSK QMS, GMP and GDP-requirements.
Master in Pharmaceutical sciences , Certified Pharmacist
Min. 2 years of experience in the pharmaceutical industry, in a quality function.
Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigor and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Able to work effectively in English
Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook
Valid driving licence
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
We also offer:
Established job in an international, well-known pharmaceutical company
Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
Opportunity to work within GSK standards and documentation applied globally
Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)
Flexible working hours
Replacement contract of employment
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our scientific and technical know-how and talented people. We strive to attract the best people and to create an environment that empowers and inspires. Explore more exciting opportunities by visiting our career site (http://www.gsk.com/en-gb/careers/) .