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4 listing(s) available.
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21 Oct 2020
Regulatory/Quality Associate
Taiwan
Contract PositionOur client is a global biopharmaceutical company focused on discovering, developing and delivering innovative medicines for patients with serious diseases. Their medicines are helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience, fibrosis and others.Job Description
- Ensures the implementation and maintenance of quality management system, for the distribution activities with company product in the Market.
- Attendance to complex issues impacting the market.
- Identifies and communicates quality issues and decisions, which impact the business.
- Ensures compliance of market Third Party Distribution partners to company Quality requirements related to distribution and transportation.
- Embraces continuous improvement activities for more effective Quality systems across the organization.
Ensure that a Quality Management System is implemented and maintained in the local market, including:
- Acts as the local Authorized Person responsible for GDP in accordance with Market regulatory requirements
- Maintains Quality System Documentation: procedures and records
- Company Policy/Directives/SOPs impact assessment and implementation
- GDP and Local regulations impact assessment and implementation
- Ensures initial and continuous GMP/GDP training programs are implemented and maintained, including product identification and avoidance of falsified
- Develops and maintains locally the Quality Manual/Site Master File
- Ensures that relevant customer complaints are dealt with effectively
- Performs periodic Self-inspections according with the self-inspection plan and puts in place necessary corrective measures
- Ensures implementation of Deviation and CAPA management
- Ensures implementation of the Change Control management
- Coordinate the Quality Management Review/Quality Council of the Market
- Reports quality metrics and Implements adequate action plans for metrics achievement when necessary
Ensures implementation of following Quality Operations:
- Suppliers management oversight: Quality Agreements, approving any local subcontracted activity which may impacts product quality, evaluate and confirm the overview of the supplier qualification status
- Product Quality status and batch release or approval to the market
- Support compliance/quality issues with the impacted market team
- Ensures On Hold products request are observed
- Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls
- Decides on the final disposition of rejected, recalled or falsified products
- Approval of the returns to saleable stock, according to Company requirements
- Support Supply Chain to avoid Back Orders
- Provide quality input on shortage situations and oversight reporting to Health Authority
- Medical samples Quality distribution oversight
- Supports of sampling requested by HA (product, procedures, reference substances)
- Keeps appropriate records of any delegated duties
Facilitate that Company requirements are implemented in the Local Distribution Centre/ Asia Distributors (as required) for:
- Warehousing facilities
- Secondary packaging facilities
- Transportation processes
Quality Risk Management
- Coordination and preparation of Quality Risk Management
- Participate in the periodic Business Review with the DC
Inspections and Regulatory Surveillance
- Maintenance of the Wholesale Distributor License with Regulatory agency
- Import certificates, when requested
- Support the Global Quality Audits in the market
- Preparation of HA inspection in local entity and leading HA inspection
- Anticipate the new directives (Regulatory surveillance)
- Site PIC/s GMP registration, maintenance and renewal
Expires on 18 Nov 2020Requirements
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Degree/Certification:
Must possess a Bachelor's degree in Sciences, preferably in Pharmacy
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Experience – Responsibility and minimum number of years:
- 3 years of progressive experience within the quality function of the pharmaceutical health care industry.
- Knowledge and experience in pharmaceutical health care operations, quality control, distribution and International regulations are essential.
- Proficient in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations; and requirements for pharmaceutical products distribution.
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21 Oct 2020
Medical Affair Specialist
Taiwan
Permanent PositionA leading force in the pharmaceutical industry, which achieved what was thought impossible by launching the world’s first “antibody biosimilar” from a country with a relatively underdeveloped pharmaceutical sector. The company has pioneered numerous uncharted areas to stellar success, which it plans to follow up by continuing its growth as a global biopharmaceutical company with unique approaches to small molecule pharmaceuticals and new businesses such as the Ubiquitous-healthcare platform business.Job Description
- Responsible for Local Pharmacovigilance Personnel for the affiliate
- Being the contact window of regulatory affairs between the HQ and the affiliate
- Provide thorough up-to-date medical and scientific expertise to drive Company's messages delivery to selected KOLs/Stakeholders of high-quality medical information on new-launches and contribute Company's Strategies with KOL insights in assigned Therapeutic area.
- Provide field-based medical support for Company's products within specific portfolio
- Support Company's strategic and scientific objectives by implementing the medical affairs strategy
- Become an expert in the therapy area by engaging with scientific leaders in the medical community externally
- Provide medical and strategic support to internal stakeholders, including developing medical-marketing initiatives, training on our products and supporting the sales team
- Analyzing clinical trends and practices
- Hosting advisory boards
- Monitoring the scientific literature for new developments
Expires on 04 Nov 2020Requirements
- Possess pharmacist license
- Possess pharmacovigilance and RA experience
- Open for junior RA or PV who is interest to enter MNC medical function
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20 Oct 2020
Manager, HR Business Partner
Singapore
Permanent PositionOur client, one of the biggest Healthcare Clusters in Singapore, is looking for a HR Manager as part of the HR Partner team, to provide HR consultation and services to senior stakeholders in corporate functions at their HQ.Job Description
- Work closely with BU to deliver and achieve business goals, and deliver a full spectrum of HR services to all levels of staff in compliance with HR policies.
- Provide guidance and solutions to stakeholders for complex employee relations issues, grievances and other performance management related matters.
- Work closely with Line Managers on performance appraisal exercise, mass salary review and bonus exercises, award nominations, and budget exercises.
- Identify and refine existing processes, propose and drive changes necessary to establish good HR practices.
- Involve in succession pipelines to develop and strengthen the managerial and leadership capabilities.
Expires on 19 Nov 2020Requirements
- Bachelor’s degree in related functions, with at least 5 years of HR business partnering experience in large organizations.
- Leadership experienced is highly preferred.
- Profound knowledge of Singapore HR law and regulations.
- Good analytical skills, comfortable working with numbers and detail oriented.
- Strong communication and interpersonal skills with the ability to perform analysis, prepare proposal and present to the senior management team.
- Able to work independently with minimal supervision.
If you are interested, apply today.
Location: Central
Interested candidates kindly forward your CV to yvonneyf.li@peoplesearch.jobs (Yvonne Li Yifang, Reg No: R2090500). Feel free to forward this great opportunity to someone who would be a great fit for this role.
All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.
PeopleSearch Pte Ltd
EA License No: 16S8057 -
30 Sep 2020
Group HR, HRBP, Senior Executive
Singapore
Permanent PositionOur client is one of the largest healthcare group and being part of the national healthcare blueprint, it is ear-marked to be one of government key areas of development with rapid expansion ranging from hospitals, healthcare professionals to allied support. Our local healthcare scene has gone through structural changes over the past few years and corporate function is also steadily expanding to support the growing needs. We are looking for suitable talent for the following role: Group HR, HRBP, Senior ExecutiveJob Description
- Partner with Heads of Department in key areas such as workforce planning, talent acquisition and development, employee retention, performance management and employee relation practices.
- Provide HR consulting to Heads of Departments on HR policies and processes and assist them in the effective implementation within their departments.
- Point of contact for all staff in the assigned job families in relation to their HR requests including advice on HR matters.
- Work closely with management and employees to improve working relationships, build morale, increase productivity and retention through assessing and anticipating business and operation challenges, organizational and employees concerns leading to facilitation of HR interventions and resolutions to conflicts, grievances and disputes.
- Collaborate and partner other HR functions in the delivery of optimal HR operation support to the line departments.
Expires on 30 Oct 2020Requirements
- Part of HR Op team
- Provide advice to HODs on strategic rationale
- Excellent communication skill, facilitate discussion and mitigate disagreement when needs arise
- Take on an advisory role and work in close partnership with BU to deliver and achieve business goals
- Work with line managers on staff management and Corporate HR initiatives
- Collaborate with HR specialist teams to ensure consistent and integrated HR support to the business
- Customer-focused mindset, proactive to reach out to the business
- Able to work independently with minimal supervision
- Possess a Degree with at least 5 years of relevant hands-on HR exp
If you are interested, apply today.
Location : Central
Kindly indicate your current/last salary details and your notice periodInterested candidates kindly forward your CV to puisanlau@peoplesearch.jobs (Lau Pui San, Reg No: R1981490). Feel free to forward this great opportunity to someone who would be a great fit for this role.
All information will be kept strictly confidential. We regret to inform that only successful applicants will be contacted.
PeopleSearch Pte Ltd
EA License No: 16S8057