QA/ra Manager

3 days ago


Singapore Superform Consulting Pte Ltd Full time

Job Title: Quality Assurance, Regulatory Affairs Manager
Location: Tuas
Working Days: Mon -Fri
Working Hours: 7.45 AM-4.45 PM

**Salary**: Basic up to $5000

Job Duties
- Manage the quality management system and audit program ensuring compliance with the standards and regulatory requirements (cGMP, FDA 21 CFR Part 820, Part 210 & 211, EU MDR, and ISO 13485).
- Provide technical data or information required by Regulatory Authority for import, reimbursement, and product registration.
- Handling company vigilance system with Regulatory Affairs personnel including product recall activity, assisting in assessing the recall class of the product recall, and assuring that the product recall is understood and complied with. Coordinate with each department and provide the required documentation and gain approval for product recalls/withdrawals.
- Independent reviewer for Equipment Qualification/Validation Program, Process, and Method Validation.
- Finalize and set up the specification for approved starting raw and packaging materials, bulk solutions, and finished products that meet the relevant standard and requirements.
- Ensure all company procedures comply with cGMP and ISO requirement and conduct reviews periodically as required.

Job Requirements
- Diploma/Degree in Life Science (Biology, Chemistry, Pharmaceutical) or Engineering.
- Scientifically, provide technical guidance on materials, products, and process evaluation or validation required by regulatory requirements with relevant education and experience.
- In-depth knowledge of the cGMP, US FDA QSR and 21 CFR Part 820, Part 210 & 211, EU MDR, ISO 13485; or equivalent
- Demonstrated success in the preparation of regulatory audits. Working knowledge of managing the quality management systems in medical device or pharmaceutical environment is preferred

WONG MENG KANG

Superform Consulting Pte Ltd

License No.: R1988500/15C7536

**Job Types**: Full-time, Permanent

**Salary**: $4,500.00 - $5,000.00 per month

Schedule:

- Monday to Friday

Supplemental pay types:

- Yearly bonus

**Education**:

- Local Polytechnic Diploma (preferred)


  • Global QA

    2 weeks ago


    Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time

    **Job summary** Lead global QA & RA team. Provide sufficient QA & RA initiation and involvement while providing product or service to customers, ensure those products or service meet all applicable regulation requirements, customer expectation and company objectives. **Responsibilities** 1. Establish, maintain and improve Quasar global quality management...

  • Ra Manager

    5 days ago


    Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-18145 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - A new entrant to the Singapore scene with a very unique product offering is looking to build out a team in Singapore to focus on the SEA market. They are currently looking for a...


  • Singapore RGF Full time

    **Location**: Singapore **Salary**: Open **Industry**: Healthcare & Life Sciences **Sub-industry**: Medical Devices **Function**: Healthcare R&D **Job Description**: **Our Client**: Our client is a Japanese Regional HQ that focuses on medical technology for infection control and laboratory uses. Their office in Singapore also manages the sales and...

  • Regulatory Affairs

    1 week ago


    Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Singapore/Pharmaceutical Division **Job Purpose** To contribute as an integral member of Client’s Singapore RA team to support all regulatory activities for Client’s products. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various...

  • Regulatory Affairs

    51 minutes ago


    Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Singapore/Pharmaceutical Division (12-mth contract) **Job Purpose** To contribute as an integral member of Client’s Singapore RA team to support all regulatory activities for Client’s products. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory...

  • Ra Systems

    1 week ago


    Singapore Roquette Full time

    Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients. Want to help us make a difference? Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients. Each of our ingredients responds to unique and...


  • Singapore Johnson & Johnson Full time

    Job Purpose - Implement and lead development of programs that will support APJ Vision RA team digital transformation roadmap. - Partner with the regulatory affairs team as well as cross functional stakeholders to build and drive digital solutions that will support workflow and strategy optimization. - Responsible for the day-to-day processing and validation...


  • Singapore HOYA MEDICAL SINGAPORE PTE. LTD. Full time

    **HSO way of working** In fulfilling our roles, we are - Accountable for our own capabilities and development. - Focused on delivering results without excuses, and - Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively. We are looking for people who - See beyond self and are impact...


  • Singapore Bio-Rad Laboratories Full time

    Responsibilities**:RA** - Audit & Inspections - Participates in regulatory agency inspections as needed and assists in dispersing the information as appropriate - Prepares, files, and submits responses to external quality surveys, tender and questionnaires - Manufacturing site - Support and perform regulatory risk assessment for CAPA, QN deviations,...


  • Singapore PSC BIOTECH PTE. LTD. Full time

    Provide validation strategy and QA oversight on computer system validation (lab equipment, process equipment, IT, automation system - DeltaV, PEMS, AMS) and equipment/system validation (vessels, fermenter, washing machine, washing cabinet, chambers, Isolator) and SIP - Review and approve validation protocols and reports including validation lifecycle...