Senior QA Validation Specialist

2 hours ago

One North, Singapore Private Advertiser Full time $80,000 - $120,000 per year

About

The QA Validation Engineer will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that all manufacturing processes, systems and equipment comply with regulatory standards and quality specification. The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operation.

We are a distinguished brand with more than sixty years of expertise in the pharmaceutical industry. We aim to broaden our presence by using Singapore as a central hub for expansion into other countries.

Responsibilities

  • Develop and execute validation protocols for facilities, equipment, utilities, materials, manufacturing process, cleaning and computerized systems.
  • Document validation activities and results and maintain records for all validation activities.
  • Analyse validation test data to determine whether systems or processes have met validation criteria.
  • Author of validation reports
  • Develop and maintain validation master plan.
  • Develops re-qualification or re-validation plans to keep the systems in validated states.
  • Support audits and inspections as a subject matter expert.
  • Provide impact assessment for any planned change to the site and execute any change actions that result from the assessment.
  • Work closely with stakeholders to coordinate validation activities.
  • Collaborate with cross functional teams to address deviations and implement corrective actions and to prepare periodic product review.
  • Train staff on validation procedures and maintain documentations for audits.
  • Maintain knowledge of current regulatory intelligence and industry trends.

Qualifications:

  • Bachelor's degree in Engineering, Pharmacy, Science or a related field.
  • Prior work experience as a Validation Engineer or similar role in the pharmaceutical industry or medical device industry.
  • Proficient with validation software tools.
  • Experience with audit management, regulatory inspections, and handling regulatory queries on validation matters.
  • Strong analytical, problem-solving, and organizational skills with a keen attention to detail.
  • Strong sense of accountability and ownership of responsibilities.
  • Excellent verbal and written communication skills with the ability to present technical concepts to cross-functional teams and senior leadership.
  • A commitment to maintaining high standards of quality, safety, and compliance at all times.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional development and advancement.
  • A dynamic and collaborative work environment.

  • Quality and Regulatory Affairs Specialist

    2 weeks ago

    One North, Singapore Majeton Pte. Ltd. Full time $60,000 - $120,000 per year

    At Majeton, weare driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products.We are seeking a meticulous and experienced Quality & Regulatory Affairs...

  • Cryptocurrency Senior Operations Specialist

    5 days ago

    North East, Singapore Tangspac Consulting Group Full time

    Description Cryptocurrency Senior Operations Specialist (ID:4838) My client, a leading cryptocurrency trading company headquartered in Singapore, is expanding their Operations Finance footprint by 1 additional permanent headcount. Company Description: Our client is a leading digital currencies trading company headquartered in Singapore, dedicated to...

  • QA/QC Executive

    4 days ago

    Woodlands, North Region, Singapore NP GROUP Full time $60,000 - $90,000 per year

    We are seeking a motivated and detail-oriented QC/QA Executive to join our team in the food manufacturing industry. This role is key to maintaining our high standards of food safety, quality, and compliance. The successful candidate will oversee bothQuality Control (QC)andQuality Assurance (QA)activities, ensuring that all raw materials, production...

  • Senior Software Design and Validation Engineer

    2 hours ago

    North Region, Singapore MIT Semiconductor Pte Ltd Full time $120,000 - $200,000 per year

    MAIN DUTIES AND RESPONSIBILITIES:Software Design & Development· Design and develop machine control and process control software for automated semiconductor equipment.Integrate software components and OEM equipment into fully functional systems.Produce optimized, testable, and efficient code with proper documentation, flowcharts, and comments.Debug existing...

  • QA/QC & PD Executive

    4 days ago

    North Region, Singapore Vitasoy International Full time $60,000 - $120,000 per year

    Key Responsibilities & duties:Establish, update and sustain effective implementation of the plant's Food Safety (ISO 22000), Quality (ISO 9001), HACCP, Organic, and Halal Management Systems and its PRP prerequisite programs, certified by 3rd party certification bodies.Responsible to support operations (incoming quality, production deviation management,...

  • Customer QA Engineer【Manufacturing 】

    2 days ago

    North Region, Singapore aa5ec4e2-22d3-4e1d-8505-4d95ed167815 Full time $60,000 - $120,000 per year

    Summary Benefit : Friendly working environment 5 days work week Career ProgressionResponsibilities :Serve as the primary liaison between the customer and the quality assurance team, ensuring customer quality requirements are met.Analyze and resolve customer complaints and quality issues through root cause analysis and corrective action.Support quality...

  • QA/QC & PD Executive

    2 weeks ago

    North Region, Singapore Vitasoy International Singapore Pte Ltd Full time $90,000 - $120,000 per year

    Key Responsibilities & duties:Establish, update and sustain effective implementation of the plant's Food Safety (ISO 22000), Quality (ISO 9001), HACCP, Organic, and Halal Management Systems and its PRP prerequisite programs, certified by 3rd party certification bodies.Responsible to support operations (incoming quality, production deviation management,...

  • Part-time Enrolled Nurse

    2 weeks ago

    North-East Region, Singapore QA Employment Consultant Pte Ltd Full time $42,000 - $66,000 per year

    Enrolled Nurse (Transport Unit)Job DescriptionWilling to work up to 12 hours Day/Night shiftsPreferably to start work ImmediateJob Responsibilities:Send and accompany patient to hospitals for medical treatment or proceduresEnsure patient's safety during the transportation and accompany patients throughout their visits to the hospitalVital signs monitoringAny...

  • QA/qc Engineers X 3

    2 weeks ago

    North Singapore JobAlpha.com Full time

    **Employer**: MNC, A1 Main Contractor. - **Location**:East & North Area. - **Salary**:$4.8 K- $6 K Negotiable, on Qualification, Experience & Capability - **Annual Leave**:17 days, Year End +Individual Performance Bonus **NOTE**: WE **DO NOT** Sponsor for **ANY Work Pass**. ** NIL, Spore Project Experience, Will NOT be Consider. ** **_ ** ONLY those who do...

  • Senior QAQC Engineer

    4 days ago

    Alexandra North, Singapore Shanghai Tunnel Engineering Co (Singapore) Pte Ltd Full time $80,000 - $120,000 per year

    The Senior QA/QC Engineer is responsible for overseeing and managing the overall quality performance of all ongoing projects from the Head Office level. The position ensures that the company's Quality Management System (QMS) is effectively implemented and maintained across projects in accordance with ISO standards, contractual requirements, and corporate...