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Quality Systems Specialist

3 weeks ago

Central Singapore PSC BIOTECH PTE. LTD. Full time

**Location**
- Singapore, Central Singapore**Job Type**
- Contract**Salary**
- $3,500 - $5,500 Per Month**Date Posted**
- 22 hours agoAdditional Details

**Job ID**
- 129545**Job Views**
- 64Roles & Responsibilities

To support the implementation and maintenance of various Quality Systems and to guarantee the quality oversight for validation related activities which includes Data Integrity at site.

**Responsibilities**:

- Support the implementation and enhancement of the quality system according to internal and external requirements
- Support the collaboration in enhancement and harmonization of Global qualification/ validation requirements
- Support the site projects on Qualification / Validation
- Support internal and external inspections Assessment and Approval of Documents
- Support the implementation of internal and external qualification/ validation requirements
- Compliance with local and global procedures
- Quality approval for qualification/ validation discrepancy
- Support the review of SOP’s
- Review/ approval of study documents
- Review/ approval of specification documents (e.g.User Requirements/ Functional/ Design Specification) on compliance with validation requirements
- Review/ approval of validation documents (e.g. risk assessments, validation plan, validation report)
- Support in the assigned Quality System(s) rollout by ensuring that the following elements of the assigned Quality System(s) is/ are implemented and maintained at the site according to regulatory, and global requirements:

- Change control management, Annual Product Review Management, Quality Improvement Program, Document Management, Investigation Program management, **IT Systems Quality**:

- Support on Supplier Quality Management (Supplier Complaints, Supplier Notification of Change, Quality Agreement, Supplier Monitoring, and SMS Trackwise System)
- Support on Material Management (Specification, Implementation which includes Material Qualification, Impact Assessment, Complaints, and support activities in regulatory, product) Process
- Support on the review/ approve the Material Qualification protocols, reports, procedures, and other related documents to ensure compliance to internal procedures and regulatory requirement
- Any other duties as assigned by Manager/ Supervisor

**Requirements**:

- Degree in Pharmaceutical Sciences, Life sciences, Biology, Biotechnology Chemistry, Chemical Engineering, Engineering or a related discipline
- Additional certification and trainings such as Certified Quality Engineer or specific Validation topics will be advantages
- Minimum experience of 2-3 years in the pharmaceutical or biotechnology in Quality Assurance, Manufacturing Operations or Validation, ideally in a multinational company
- FDA/EU cGMP validation requirements/expectations (eg. CFR 21 part 11, PAT) and a thorough understanding of ICH guidelines and the various validation guides such as PDA Technical guides, ISPE GAMP guides etc
- Able to logically solve problems in order to find timely solutions
- An ability to interact and communicate with all types of personalities in an effective and diplomatic manner
- ** Must be comfortable with contract basis role**

Tags

quality

systems

specialist

data

integrity

mes

pharma

contract