Quality Assurance Executive/ Quality Assurance Senior Executive

Cellvec; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A biotechnology company in Singapore is seeking a document management and quality assurance professional. You will create and review SOPs, manage GMP documentation, and support audits. Ideal candidates have a strong background in quality assurance and document lifecycle management. This role offers opportunities for collaboration with various departments and involvement in supplier assessments.

Qualifications

• Experience in creating and reviewing Standard Operating Procedures (SOPs).
• Familiarity with GMP documentation and quality assurance processes.
• Ability to manage document lifecycle and maintain archival systems.

Responsibilities

• Create and review SOPs in accordance with internal policy.
• Manage and maintain the existing systems for efficiency and improvement.
• Support deviations and internal audits/inspections.

Skills

SOP creation and review

GMP documentation management

Quality assurance review

Collaboration with departments

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