Quality Control Supervisor ( Pharma Business)

Quality Control Supervisor ( Pharma Business)

GlaxoSmithKline Pte Ltd
3-5 years
Not Specified

Job Description


Job Description :
Site Name: Vietnam - Ho Chi Minh City Posted Date: Sep 14 2021 As a Quality Control Supervisor , you will will become person to ensure quality operations and systems in the GSP warehouse are in compliance with the rules and regulations of the regulatory agencies (WHO GSP, GDP and part of GMP) Quality Control Supervisor is required to coordinate and collaborate cross-functional team to perform quality operations through E2E product flow and ensure quality team in warehouse in charge of quality operation coordinates with relevant stakeholders for: Regulation compliance check of incoming goods and make sure right status of received products. Disposition to release/quarantine/reject products and repacking materials. Verification of irregular goods, quarantined/suspended stock, recalled products. Perform and supervise all transaction on quarantined/ rejected stock. Verification of returned goods to make sure product quality as requirement of processes. Authorising the return to saleable stock of any returned medicines. Coordinate with warehouse for repacking plan. Ensure repacking activities are carried out in line with processes, manufacturer's instruction and regulation/standard compliance. Supervise and implement repacking of products. Ensure that the repacking process is carried out in accordance with the prescribed requirements. Products to the market must have information in accordance with the requirements of the law. Verify, approve for results from operation activities (i.e. storage condition monitoring, pest control, device calibration) Perform the validation and requalification per GSK requirement regularly in regard to facilities, utilities, equipment, cleaning, transport processes. Perform validation activities (i.e. mapping) by process witness, materials checking, data verification if requested. Provides support for the implementation and/or maintenance of a documentation structure, SOP training and related local processes, enabling common Quality Systems and documents to be used within affiliate, including maintenance of accuracy of quality records, version updates and effectivity, periodic record review, obsoleting and archiving. Ensure documentation control (i.e. SOP distribution, training records, batch records) is properly managed. Generate and update controlled documents (e.g., procedures, forms, reports) as needed, to ensure compliance with applicable quality objectives and regulatory requirements. Ensure change control/deviation documents related to site activities are verified and well documented. Deviation and failure investigation. Tracks the shipping complaints associated with the distribution to ensure they are appropriately reported, recorded and resolved on a timely basis. Participate in quality incident investigation and Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain. Ensuring that relevant customer complaints are dealt with effectively including complaint investigation. Coordinating and performing promptly any recall operations of medicinal products. Participate and support audits, follow up post-audit. Quality inspection (management of monitoring). Internal audit (Independent business monitoring) Support the Third Party audit if assigned Participate in external compliance audits, regulatory inspections as required. Support to achieving GSP, GDP and part of GMP certification, to ensure a compliant GSK Quality Management Systems. Perform & support gap analysis and risk assessments on processes and evaluate compliance to relevant GSP, GDP and part of GMP regulations/guidelines & implement/support the implementation of corrective actions, prevent action. Perform LSOPs quality training and personnel qualification programs (day to day, routine operational basis) Ensures all personnel are trained in GSP, GDP for their own duties, including product identification, the risks of falsified medicines and specific training for products requiring more stringent handling. Internal/External Customer & Partners Satisfaction Build network with cross functions in order to build a transparent and consistent working environment within the company. Assist GSK VN build quality culture and quality event. Contribute to GSK as be the quality ambassador in field. Training/ skill enhancing Participate in training course in My-learning/conducted by local Quality team/Region Quality team/CERPs/SAP/departments SOPs. Ensure quality induction training take place at LOC and third party under scope. Key Deliverables (Success Measures & KPI's): Maintain GSP Certification and Compliance for operations. Maintain GMP Audit Certification and Compliance for operations. QMS Compliance GSP Warehouse Operations LSOPs In place and In use E2E Batch release. Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree or equivalent At least 3-5 years at minimum of professional experience in GSP, GDP and GMP and Quality management system. 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. English: fluent oral & written communication skills Profiency in MS Office/knowledge in SAP or ERP. Relationship building & networking capability Leadership ability Good communication & inter-personal skills. Ability to support and challenge at the same time senior leaders Preferred Qualifications: If you have the following characteristics, it would be a plus: Developing knowledge and application of the QMS (Quality Management System). Knowledge of company products and quality impact as it relates to those products. *LI-GSK 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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