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GlaxoSmithKline QA Executive & QP Pharmacist in United States

Job Purpose

The job exists within the commercial Local Operating Company to ensure quality of the product released to the Israeli market. This is based on GSK Quality Management Systems(QMS).

  • Qualified Person is a critical function to the effective management of product quality, availability & supply which are crucial and has a direct impact on regulatory compliance, patients & consumers.

  • The job holder is expected to take the lead in implementing and sustaining the QMS with the LOC. including encouraging the Commercial CH business to own quality activities in their day to day work, by strengthening quality awareness.

  • The job holder has a strong partnership with all functions to support implementation and roll out of the QMS, including but not limited to regulatory, medical, compliance, legal, supply chain (including customer services), marketing, and commercial.

  • Using an active mindset, will generate creative solutions for technical problems.

  • Job holder supports the LOC Quality Lead for key objectives: facilitate quality management and, the development of a right first-time quality culture and facilitate development of the LOC Quality Improvement strategy.

Key Responsibilities:

Implement and maintain effective Quality Assurance systems to ensure that local operations are in full compliance with GSK standards and policies, GMP, GDP and regulatory requirements by performing the following:

Batch Release

  • Responsible for approving or rejecting batches to the Israeli market in an efficient way and meet the compliance standards of the QMS and the local regulator.

  • Reviewing all batch related documents to ensure alignment with all products' registered details, specifications, variations, and commitments. Verification that products are in line with approved labeling packs and inserts.

  • Responsible for confirming all relabeling activities are in accordance with GSK and MoH regulations. Verification of quality of all imported products before release to market i.e. manufacturing\shipping deviations. Approving batch release & issue of Batch Release Re-Certification Documentation to MoH and local distributers.

  • Point of contact for MoH for batch release related matters and GMP topics including incidents and recalls. Ensuring appropriate and sufficient documentation of batch records and retained samples in accordance with MoH and GSK policies. Confirming all appropriate quality agreements are in place.

  • Reviewing \ assessment of Product Quality complaints and Product Quality Reviews as appropriate.

  • Establishing and maintaining close relationships with manufacturing sites and QP's. Team work with local management functionaries.

Quality Systems

  • Confirm and sustain effective Quality Assurance systems are in place to ensure that local operations are robust, sustainable, effective and fully compliant with Israeli MoH regulatory requirements and policies, GMP & GDP and with QMS. Support the LOC Quality Lead to ensure that all internal procedures and systems in use in the LOC are aligned and compliant with MoH regulatory requirements and policies such as: Quality Council, Change Control, Risk management, Corrective and Preventive actions, Auditing, Complaints, Incident Management, Product supply and Artwork management.

  • Confirm Effective complaints management process in place to meet MoH regulatory requirements.

  • Confirm all matters pertaining to regulatory and QA compliance for local repacking procedures are in place to ensure alignment with local registration and QMS to enable timely batch release of repacked orders before distribution. Product supply- take part in development and approval of local systems that have an impact on the quality of imported, products in line with all MoH requirements and QMS accountable for approval of Quality Agreements, TTS (Technical Terms of Supply) and liaison with manufacturing sites to ensure compliance to local registered technical details.

  • Liaison with External Supply Quality for products that are manufactured by contractors to ensure compliance to local registered technical details. Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries. Acts as the primary liaison with the GMS supplying sites, as it relates resolving Quality issues with the product supplied.

  • Liaison with local logistics to ensure GDP requirements are met.

  • High level understanding of commercial LOC business and Quality Plans as they potentially link to day to day and quality improvement activities.

  • Effective local product incident process in place and in use to escalate and manage any product quality related issues. Must be well documented process and link into Quality Council as well as into above country PIRC process. Develop local processes based on global ones to conduct root cause analysis to investigate GxP deviations and develop CAPA's, manage incident communication to MoH, manage Recalls, point of contact to Israeli MoH

Auditing:

  • Confirm Local process in place for management monitoring and internal business monitoring., Confirm Processes in place to ensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by QA team according to agreed audit schedule. e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers. Conduct/Approve all level suppliers/ 3rd party contractors/ service providers audits managed at local level.

  • LOC QMS Champion - QMS champion oversees LIA process, ensuring that global procedures and local procedures are implemented as per plan, Author/contributor for local SOP, WoW, WI, spoc for the areal QMS team

  • The function is critical to the effective management of systems and activities that are crucial or have a direct impact to product quality and regulatory compliance. The job holder is expected to take the lead in implementing and sustaining the QMS with the LOC/LOCs. including encouraging the Commercial CH business to own quality activities in their day to day work, by strengthening quality awareness.

  • The QMS Champion has a strong partnership with all functions to support implementation and roll out of the QMS, including but not limited to regulatory, medical, compliance, legal, supply chain (including customer services), marketing, and commercial.

Requirements:

  • Successful completion of relevant tertiary qualifications - Pharmacy degree.

  • 2 years of experience in analytical laboratory, alternatively qualified in relevant course as defined by the MoH.

  • Formally approved by the MoH to conduct batch release to market as defined by the Israeli Pharmaceutical regulations {The Pharmacists' Regulations (Good Manufacturing Practice for preparations), The Pharmacists' Regulations (preparations)} and MoH Guideline EX-004.

  • Quality experience within the industry, and application of Quality Systems & Quality Operations

  • Knowledge of the Pharmaceutical legislation , MoH SOP's, and guidelines

  • Knowledge of updated European GMP guidelines regarding parts relevant to QP's job.

  • Knowledge of Israeli SOP's and guidelines regarding product registration.

  • Knowledge of QP's job and professional duties.

  • Minimum of 2 years' experience within the Pharmaceutical/Consumer Healthcare industries.

  • Strong understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits

  • Strong knowledge of regulatory requirements pertaining to GMP/GDP

  • Good knowledge on effective quality documentation systems

Job-related Experience:

  • Being able to understand ways of working in a Regulated Industry, as defined by the Israeli Pharmaceutical regulations and MoH Guideline EX-004.

  • Professional written and verbal communication skills. Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization

  • Ability to influence and motivate stakeholders at any level of the LOC organization

  • Analytical mind, good attention to detail and problem-solving skills within a structured process

  • Good team player – works well in cross-functional teams

  • Good time management skills, with ability to multi-task and work under pressure

  • Concise and persuasive in the description of the different QA situations. Able to stick to the standard and not be pressurized.

  • Works with a spirit of continuous improvement and innovation, creatively open to new ideas and methods

  • Flexible thinking – able to challenge and see views from different perspectives

  • Ability to self-motivate and be resilient and focused under pressure

  • Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook

  • Able to work effectively in English

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/) .

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