• Phone: +86 21 63862192
  • Mailbox: info@alphabiopharma.com
  • Shanghai: Unit 04-08, 5F, Platinum Building, No.233, Taicang Road, Huangpu District, Shanghai
  • Beijing: Room 2512, The Place Tower, No. 9 Guanghua Road, Chaoyang District, Beijing

Talents Value

Organizational capability refers to the combat effectiveness of the entire team

  • Sustainable and embedded in the organization rather than the individual

    Sustainable and embedded in the organization rather than the individual

  • Create values to the customer

    Create values to the customer

  • Significantly surpass the competitor

    Significantly surpass the competitor

The organizational capability of the smart company needs a focus, which demonstrates 2-3 aspects as core competencies. The organizational capability also needs to be clearly defined, which aims to focus on development of those capabilities.

  • Employee Mindset

    Employee Mindset

    whether employees show their values, behaviors and engagement to match their organizational capabilities?

  • Employee Capability

    Employee Capability

    whether employees have knowledge/skills/qualification required for organizational capabilities?

  • Employee Governance

    Employee Governance

    whether the company can provide management support & resources, allowing employees to give full plays to their strengths?

3 dimensions to strengthen organizational capabilities

2 Principles for 3 dimensions to strengthen the organizational capabilities:
Balance - 3 dimensions to be equally strong;
Matching - focus of 3 dimensions to be aligned with the necessary organizational capabilities.
3 dimensions to strengthen organizational capabilities

Employee Activities

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ICON

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Employee Development & Training

  • New Employee Orientation

    New Employee Orientation
  • General Management Skill Training

    General Management Skill Training
  • Professional Skills Training

    Professional Skills Training

Training System

  • On-site trainingOn-site training
  • Live-stream trainingLive-stream training
  • Lunch-time seminarLunch-time seminar
  • Offline salonOffline salon

Employee Welfare

  • Annual Leave
    Annual Leave
  •  Sick Leave
    Sick Leave
  •  Business Insurance
    Business Insurance
  •  Annual Outing
    Annual Outing
  •  Physical Examination
    Physical Examination
  •  Birthday Party
    Birthday Party
  •  Afternoon Team
    Afternoon Team
  •  Vacation Welfare
    Vacation Welfare
  •  Team Building
    Team Building
  •  Shuttle Bus#
    Shuttle Bus
  •  Employee Dormitory#
    Employee Dormitory
  •  Welfare Lunch#
    Welfare Lunch

icon exclusive welfare for factory employees

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Talents Acquisition

QA Manager, QMS

  • Work Place:上海
  • Release Time:2021-09-27
  • Number Of Recruits:1 Person
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Job Description

QMS
Establish and continuously improve the assigned quality systems in line with the regulatory expectation as the system owners

Product Quality Assurance
1.Ensure the compliance of quality relevant tasks (e.g., Deviation, change management , CAPA follow up, etc.)
2.Act as QA representative in the project, and perform QA operational tasks timely. 3.Responsible for the release of the material.
4.New supplier qualification and management
5.Execute the random tasks assigned by QA head.

Job Requirements

1. At least bachela degree.
2. Major in bioengineering, pharmacy, etc.
3. Experience in Cell therapy project is preferred.
4. At least 5 years QA working experience in GxP system as well as experience in working on an international level.
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Associate Director, Clinical Pharmacology

  • Work Place:上海
  • Release Time:2021-09-27
  • Number Of Recruits:1 Person
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Job Description

1. With experience managing data, writing and reviewing clinical pharmacology/PK reports and regulatory submissions dossier and responding to regulatory queries.
2. Conducts clinical pharmacology studies in line with product development strategies, regulatory requirement and scientifically sensible; Collaborate with the investigator sites, investigators, CRO or other Partners and ensure high quality standards of their deliverables.
3. Serves as clinical pharmacology expert in the assigned project team; leads the study design and coordinates pharmacokinetic / DMPK related elements for projects.
4. Manage PKPD analysis for understanding of PKPD relationship for drug effect and dose selection.
5. Oversees PK, PK/PD and DMPK biopharmaceutical analyses performed with a variety of tools and approaches.
6. Identify potential risks and provide mitigation strategies from DMPK perspective.
7. Review and ensure PK or PD analysis plan and report in phase I, II and III .
8. Representing the clinical pharmacology during the Communication with HA.
9. Assists with managing timelines and budgets to ensure efficient execution of clinical pharmacology studies.

Job Requirements

1. Advanced training with a degree of Master, PhD, PharmD or MD.
2. 5-8 year's industry experience with investigation of drug metabolism, transporters, and bio-transformations of therapeutics.
3. Knowledge of bioanalytical expertise, PK, metabolism, drug interactions, and regulatory requirements.
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Sr. Manager, Quality Assurance

  • Work Place:上海
  • Release Time:2021-09-27
  • Number Of Recruits:1 Person
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Job Description

1. Auditing
Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders (e.g. Clinical Operations, PV), and interacts with various teams to ensure corrective and preventative actions are taken to bring audit observations to closure as applicable. Activities may include routine and directed audits of investigator sites, vendors, regulatory documents and marketing applications, third party collaborations and due diligence activities.

2. Risk Management
Perform risk assessment and evaluate in area of responsibility.
Proactively identifies analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk based QMS assessments and to support the implementation of associated risk mitigation strategies.

3. Issue Management
Supports Significant Quality Issues management, including assessment of potential root causes and CAPA development.
Ensures appropriate and timely escalation of systemic problems and quality issues, including potential misconduct or issues

4. Controlled Document Management
Supports the development of SOPs to ensure alignment with local laws and regulations.
Participates in the development/enhancement of QA procedures, guidance documents and audit tools.

5.Inspection Readiness / Inspection Management
Actively involved/leading pre-inspection preparation activities in collaboration with business customers/partners.
Prepares and educates internal and external business customers/partners (incl investigator site staff) on inspection management.
Hosts and /or participates in inspection(s).
Responsible for inspection response management and tracking through resolution.
Actively participates in lessons learnt/shared learning.

6. GCP and/or GVP & QA Expertise
To provide GCP and/or GVP compliance interpretation, consultation, training. Act as a subject matter expert to respond to GCP and/or GVP compliance inquiries.

Job Requirements

1.Knowledge of ICH guidance, China local regulations, new drug regulations and current industry practice .
2. Knowledge of Quality Management Systems principles, including policies, procedures and processes.
3. Proficient written and spoken English language skills 良好的英语听说读写能力.
4. Education/Certification :
Bachelor's Degree or equivalent in scientific or health related area.
5. Professional Experience
A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least2~3 years of previous Quality related experience. Experience in conducting a broad range of audits is preferred.
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