Quality Systems Specialist

3 years exp

**Roles & Responsibilities**

**Role Objective**:
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 Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification) protocols, reports and other related documents to ensure compliance to internal procedures and regulatory requirements.
- Quality oversight for validation maintenance including Quality Control related (Analytical Instrument Qualification, Analytical and Microbiology Method Validation, Critical Reagent Qualification)
- 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
- Responsibility to adhere to any applicable EHS requirements
- Commitment to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct
- 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
- Hands-on experience with hands-on experience in performing equipment, process, cleaning, computer systems & shipping validation will be advantages
- 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**

**PSC Biotech Pte. Ltd.** is the industry recognised leader in Validation and other Quality and Compliance services. Our full time consulting staff provides a broad range of outsourced services to the biotech, pharmaceutical, medical device and diagnostic industries.

**PSC Biotech Pte. Ltd**. is also one of the leading BioPharma consulting firms in the United States. Combining experience and our technology, PSC creates innovative workforce initiatives and long-term solutions to the pharmaceutical industry.