QA Manager

QA Manager

GlaxoSmithKline Pte Ltd
5-8 years
Not Specified

Job Description


Job Description :
Site Name: Vietnam - Ho Chi Minh City Posted Date: Jul 26 2021 As a QA Manager, you will be responsible for ensuring the implementation of mandatory topics in the GSK Quality Management System is performed consistently at GSK and oversee third party contractor/vendor, supporting to the QA Director to ensure compliance of the Quality Systems, Operations, Regulatory and Good Storage Practices (GSP) and part of Good Manufacturing Practices (GMP) Compliance of Vietnam and GSK requirement This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Key Responsibilities Maintains the Quality Management Manual and implementation of all requirements of the Quality Management Manual. Plans, implements and monitors the procedures and processes for Quality Assurance at GSK. Conduct impact assessments and implement any updates to GSK QMS policies per assignment. Perform QMS gap analysis per assigned quality topics. Management of quality documentation, including creation or/ and review/ approval of documentation with GSP, GDP and part of GMP impact and record retention and archival. Serves as the Training Coordinator to establish the Training Profiles of employees and ensure the training must be processed. Monitor quality training and personnel qualification programs. Perform Management of Monitoring and Independent Business Monitoring and Follow-up of corrective and preventive actions programs. Supervise and monitor the CAPA from GSK GMP audit to ensure CAPA submit on time. Quality management of local vendor and sub-contractor: audit, qualification, approval and quality agreement approval related GSP warehouse and operations. Perform & support gap analysis and risk assessments on processes and evaluate compliance to relevant GSP and part of GMP regulations/guidelines & implement/support the implementation of corrective actions. Responsible for the review, approval and record keeping of Quality Systems records: CAPA, Complaints, Deviation, Change control etc... Handle customer complaint and counterfeit in market. Monitor Pharmaco-Vigilance reporting and implementation. Perform the review and approval of TTS (Technical Terms of Supply), QAg (Quality Agreement) and liaison with manufacturing sites and External Supply Quality to ensure compliance to local registered technical details. Ensure artwork communication update to date and on time. Assist QA Director organizing Quality council and Risk management review Assist QA Director organizing Local Incident Committee and Product recall. Organize to perform Product recall simulation Responsibility for quality KPI reporting to management team. Responsibility for supervising e-system reporting applied if applicable. Review batch release documentation and provide stock disposition. To internal approve for release or reject products at warehouse by assignment if required Final approval on receipt and dispatching or rejection of vaccines/ pharmaceutical products which are imported from overseas manufacturers by assignment if required Verification that facilities, utilities, equipment, cleaning, transport processes are qualified and validated Monitoring of equipment requiring Validation and Requalification Internal/External Customer & Partners Satisfaction Build network with cross functions in order to build a transparent and consistent working environment within the company. Assist QA Director build quality culture and quality event. Contribute to GSK as be the quality ambassador in field. Build network and partnership with local authorities in working on quality matters. Training/ skill enhancing Participate in training course in My-learning/conducted by local Quality team/Regional Quality team/CERPs/SAP/departments SOPs. Ensure quality induction training take place at GSK and third party under scope. *LI-GSK Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree At least 5 years at minimum of professional experience in GSP, GDP and GMP and Quality management system within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a quality management level. English: fluent oral & written communication skills Preferred Qualifications: If you have the following characteristics, it would be a plus: Stakeholder management (internal and external): Strong leadership, mentoring, and interpersonal skills with the ability to interact with personnel at all levels. Strong organizational and project execution skills, with to ability to effectively manage multiple tasks, priorities, and deadlines in a fast-paced environment. Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits Knowledge on effective quality documentation systems Ability to deliver clear communications and good working relationships with peers and management Why GSK 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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour 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. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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.

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