QA Validation

About Nd Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe. We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy...

**Key **Responsibilities** Your responsibilities include, but are not limited to: - This position will support operational readiness of a new facility. - Establishment of QA Validation procedures (drafting and reviewing QA Validation functional SOPs). - Act as SME to develop commissioning, validation and qualification procedures, train and guide site...

Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility. - Write reports summarizing results and statistics for all validation projects. - Review existing validation reports and identifies gaps for compliance. Develop strategies and plans to close the gaps in an efficient and technical...

Validate and qualify parts, processes and products as requested to ensure compliance to QMS. - Implement and follow-up of CAPA and Process Change Control systems. - Create cleaning validation protocols for PQ - Approval and review of all Data Integrity - Serve as Point of Contact for QA Validation - Review and approve all validation/qualification documents...

Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines. - Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility. - Preparation and review...

**Position: Quality Assurance Validation Engineer** We are Coalesce Management Consulting - a community of people with a strong Passion for Excellence. We deliver bespoke project solutions within Life Science and Technology sectors by Consultative through our community of High Calibre Industry specialists. We are currently expanding our team and are...

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...

We are Coalesce Management Consulting! A community of people with strong Passion for Excellence We deliver bespoke project solutions within Life Science and Technology sectors by Consultative through our community of High Calibre Industry specialists. Our approach is Simple but meaningful - We Grow by Helping Others Grow, We pride ourselves on providing...

Roles & ResponsibilitiesResponsibilities:Review of qualification documents such as URS, DQ, IQ, OQ and PQ protocol for automation systems and equipment in compliance with the cGMP and site SOPs. Preparation and review of automation systems, process, and cleaning validation protocols and reports. Perform Quality Risk Assessment to determine criticality of...

Roles & ResponsibilitiesResponsibilities:Review of qualification documents such as URS, DQ, IQ, OQ and PQ protocol for automation systems and equipment in compliance with the cGMP and site SOPs. Preparation and review of automation systems, process, and cleaning validation protocols and reports. Perform Quality Risk Assessment to determine criticality of...

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...

PES is an international services company providing Project Management, Construction Management, Commissioning and qualification, and Automation services to our clients in the pharmaceutical, nutritional, and related sectors. With offices across Europe, Asia, and the US, our core focus is on consistently delivering high-quality outcomes for our multinational...

**QA Associate**: The QA Associate coordinates and conducts activities of the Quality Assurance Department to provide overall site function support included manufacturing floor support and ensure quality oversight throughout the facility's operational hours for all ongoing GMP activities. **Your responsibilities include, but are not limited to**: -...

**Key Responsibilities**: **Proactive Quality Assurance**:Ensures compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing, and maintaining Quality systems. Manages staff that performs the following functions: Reporting, tracking and trending site Key Performance Indicators; Review and...

Roles & ResponsibilitiesResponsibilities● Maintaining effective qualification and validation systems, ensuring compliance with the latest regulatory expectations.● Review and approve qualification and validation-related procedures.● Perform commissioning and qualification activities at the WuXi XDC Singapore site● Review and approve...

**Job Title**: QA Engineer (South west/5 Days/AWS)Industry: Chemical / Biochemical / PetrochemicalSalary: SGD 2500 - 3000Location: South West, SingaporeAbout Company: Our client was established in 1997. A wholly owned subsidiary of a major chemical company in Japan. They produce Super-Pure Hydrogen Peroxide and Ammonium Hydroxide for the semiconductor...

**Job description** **Responsibilities**: - POC and coordinator for data integrity projects, ensure company’s quality requirements and agencies’ requirements are met. - Quality oversight for automation qualifications (Delta V and BAS) and GMP equipment qualifications - Review and approve of qualifications - related documentations (protocols and...

Your Role About the job - Support equipment qualification, system qualification, and cleaning validation. - Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. - Manage qualification execution and lead validation...

**Job description** **Responsibilities**: - POC and coordinator for data integrity projects, ensure company’s quality requirements and agencies’ requirements are met. - Quality oversight for automation qualifications (Delta V and BAS) and GMP equipment qualifications - Review and approve of qualifications - related documentations (protocols and...

Position: QA Engineer - Well Established US Manufacturing MNC - Working hours: Monday - Friday (8.00am to 5.15pm) - Salary (commensurate with experience): up to $4,000 + AWS - Working Location: Tuas - Company transport provided - Duration: Permanent - Industry: Manufacturing **Main Responsibilities**: - Involved in validation documentation for new...