Regulatory Affairs & Quality Assurance Executive
Singapore, Singapore
Job Description
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Purpose: To operationalise efforts that ensures the company\xe2\x80\x99s products and solutions complies/exceeds the regulatory requirements, provides assurance(s) in quality to meet/exceed set specifications, and promotes the growth of the business in Asia.
Main Duties:
- To operate and support the objectives and duties of the Regulatory Affairs & Quality Assurance department in enhancing and assuring the products and solutions meets/exceeds the regulatory requirements, standards of quality, and promotes customers\xe2\x80\x99 satisfaction.
- To support and fulfil the enquiries, documentation, declarations, and requirements of institutions / authorities enforcing standards and regulations in the region, as per department manager direction.
- To identify, research, review, facilitate and support the department manager on addressing issues pertaining to certification, quality and standards of the company\xe2\x80\x99s products and solutions (e.g. Good Manufacturing Practices (GMP), Halal certification, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH),etc.).
- To liaise, facilitate and support the end-to-end movements of raw materials, processes, and final products, through the provision of accurate documentation/reporting (e.g. declarations, technical papers, dossier, product instructions, etc.) as required by other departments (e.g. logistic, sales, etc.) and different offices of Kyowa Hakko Bio. Also, to liaise with relevant external parties that requires assurances in the products through delivery of technical documentation, presentations or other appropriate methods.
- To liaise and work with relevant parties (internal and external parties) in obtaining, documenting, reviewing and recording technical documents (e.g. product specifications/instructions, MoA, CoA, MSDS, packing specification, SDS, etc.); and ensuring quality, methodologies, analysis and outcomes meets/exceeds current established requirements.
- To review, report, record, update and action to achieve the company\xe2\x80\x99s internal regulatory affairs activities, customer\xe2\x80\x99s technical/specification enquiries (including Pharmacopeia compliance) and the company\xe2\x80\x99s response, quality assurance efforts, and any other initiatives that impacts the products\xe2\x80\x99 quality, standard and stated assurances, as per department manager direction.
- Schedule, support/manage, and execute internal/external audit(s) on the quality/standards in new/old products, raw material(s), preparation/manufacturing methods and processes, packaging of materials and products, storage, and transportation of the goods, to ensure compliance to the company\xe2\x80\x99s, regulators and standards bodies/institutions\xe2\x80\x99 requirements. Also, to assess, record, and report to the department manager on areas that pose current or potential risk(s) and shortcoming(s), and possible Corrective and Preventive Actions (CAPA).
- To investigate, analyse, and report to department manager of internally/externally established challenges on quality (e.g. product efficacy, cargo damage, product complaints, certification, etc.) or non-conformity to assured standards. Also, establish resolution with department manager in addressing experienced challenges while meeting the company\xe2\x80\x99s objective(s) and established standards/requirements.
- To document, report, record and update internal records of customer requests or complaints, audit results, quality incidents/issues (with evidence/observation and resolution included), technical requirements/updates to be accessible and reviewed by the department manager.
- To collaborate closely with other departments and the management to protect the value offering of the company and to support the achievement of the company\xe2\x80\x99s planned objectives.
- To adhere to the philosophies and policies established by the organization.
- To support the ongoing efforts of the organization to achieve aspired and planned goals/outcomes.
- To support fellow employees and leaders of the organization to achieve positive business outcomes.
- To work and operate within the boundaries of legal regulations, the values of the organization, and the standards established by the company and industry.
- Reporting to and actively supporting the Regional Regulatory Affairs & Quality Assurance Manager.
- Work closely with \xe2\x80\x98Sales\xe2\x80\x99 department to support customers\xe2\x80\x99 enquiries.
- Work closely with \xe2\x80\x98Accounting\xe2\x80\x99 department for financial matters.
- Work with \xe2\x80\x98Logistic\xe2\x80\x99 department (both locally and globally) for logistic and warehousing arrangements, audits, and documentation.
- Work with the company\xe2\x80\x99s global manufacturing plants on to secure the company\xe2\x80\x99s product quality and standards, and to facilitate precise policing and reporting.
- Work with regulatory bodies to update and comply with regulatory requirements when needed.
- A minimum of a Bachelor\xe2\x80\x99s degree in a related subject.
- A minimum of 1 year of Quality Assurance / Regulatory Affairs experience in a company manufacturing of pharmaceutical, or nutraceutical products.
- Strong ability to write technical documentations and reports.
- Good interpersonal skills that support a small and highly interdependent team.
- Strong ability to communicate clearly with others of varied levels and culture, to achieve main responsibilities.
- Confident command of English.
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Job Detail
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Job IdJD1300452
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationSingapore, Singapore
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EducationNot mentioned