Quality Assurance Executive/ Quality Assurance Senior Executive

CELLVEC PTE. LTD.; Singapore; On-site; SGD 40,000 - 60,000; Full time

Job summary

A leading biotechnology company in Singapore is seeking an experienced Quality Assurance Specialist to develop and manage Standard Operating Procedures (SOPs) and ensure the efficiency and compliance of documentation processes. The ideal candidate has strong organizational skills and experience in quality management systems. This role offers an opportunity to work closely with various departments to improve quality processes and perform supplier validation audits.

Qualifications

• Experience in creating and reviewing Standard Operating Procedures (SOPs).
• Ability to perform QA reviews and approve validation lifecycle documentation.
• Strong organizational skills for document and records management.

Responsibilities

• Create and update SOPs according to internal policies.
• Manage GMP manufacturing documentation, including archiving.
• Support deviations and change control processes.
• Conduct supplier validation audits.

Skills

Knowledge in management of electronic QMS

Document management

Root cause analysis

Job description

Job Description

• To create and/or review and update existing SOPs in accordance with internal policy.
• To assist and develop, draft and review SOP’s
• Control, issue, reconciliation, and archive of GMP manufacturing documentation including batch manufacturing records and logbooks both manually and electronically. Printing, issuing and reconciliation of labels.
• Perform QA review and approval of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) protocols and reports.
• Manage and maintain the existing system for continuous efficiency and improvement.

Responsibilities

Documents, Records and Data Management

• Drafting and updating of Standard Operation Procedures (SOPs)
• Ensure the correct and timely input of database entries;
• Overseeing the entire lifecycle of documents, from their creation and distribution to their eventual archiving.
• Maintains the document archival room; Responsible for filing and maintenance of all controlled documents and records;
• Checks format and conformance to document templates; Implementing version control measures, ensuring that the most up-to-date versions of documents are accessible.
• Addressing and resolving any technical issues related to document access, retrieval or formatting.
• Engaging in ongoing collaboration with different departments to coordinate document-related activities.
• Archiving older documents and efficiently retrieving necessary information when required.
• Provides additional support and assistance on tasks and projects as directed by management; Knowledge in management of electronic QMS is an added advantage.

Deviations, Change Control and Audits Management

• Support deviations (e.g. test OOS, EM excursion) initiation, investigations and root cause analysis for product defects and quality lapses.
• Support change control and CAPA implementation.
• Support internal and external audits/inspections.

Supplier Qualiifcaiton

• Carry out supplier validation audits remotely or on-site.
• Manage the root cause analysis and corrective actions process of supplier quality issues and Perform on-site supplier visits for investigation.
• Perform requalifacation of suppliers