QA Operations Specialist (Pharmaceutical Manufacturing)

Private Advertiser; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

A pharmaceutical manufacturing company in Singapore is seeking a QA Operations personnel to ensure compliance with quality standards and regulatory requirements. The role involves maintaining the Quality Management System, conducting internal audits, and collaborating with teams to improve quality systems. Ideal candidates should have a Bachelor's Degree in a Science-related field and 5-7 years of experience in Quality Assurance or Quality Control within the pharmaceutical industry. Competitive salary and opportunities for development are offered.

Benefits

Competitive salary and benefits package

Opportunities for professional development

Dynamic work environment

Qualifications

• Minimum 5-7 years’ experience in the pharmaceutical or medical device industry.
• Experience as Quality Assurance, Quality Control, or Quality Compliance personnel.
• Ability to collaborate well across departments.

Responsibilities

• Review in-process monitoring and batch records in production area.
• Maintain the documentation system in compliance with GxP.
• Conduct investigations related to production or analytical results.
• Perform material release and batch release.
• Obtain and maintain HSA manufacturer license.

Skills

Problem solving

Organizational skills

Ownership

Accountability

Education

Bachelor Degree or equivalent in Science-related field

Job description

About

The QA Operations personnel will play a vital role in establishing and maintaining high-quality standards at a growing pharmaceutical manufacturing startup. This position ensures that 1) the Quality Management System (QMS) of the company complies with regulatory requirements and industry standards and 2) manufactured products are safe and efficacious.

The incumbent will support continuous improvement initiatives and collaborate with cross-functional teams to build robust quality systems for a successful, compliant manufacturing operations.

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

1. QA Operations

• Stationed at the Production area to review in-process monitoring and batch records.

• Stationed at the QC area to review in-process control and analytical records.

• Conduct investigations related to production or analytical results.

• Provide inputs to deviations and change controls.

2. Quality Management System

• Create, maintain and improve the documentation system to be in compliance with GxP guidelines and local regulations.

• Develop and manage the training system, including conducting annual GxP refresher training.

• Retain document and records based on GxP and regulatory requirements.

• Initiate and assess planned changes. Create and complete related actions. Coordinate the implementation of the planned changes.

• Initiate, assess and investigate deviations. Create and complete related CAPA.

• Initiate, complete and track CAPA eg from deviation, product complaint, Quality Management Review, Product Quality Review, supplier review and risk assessment.

• (Re-)Qualify suppliers eg via questionnaire or audit. Create and maintain an Approved Supplier List.

• Establish and maintain Quality Agreements with suppliers and service providers.

• Conduct internal audits periodically.

• Host and participate in GMP-GDP inspections.

• Conduct Quality Management Reviews (QMR).

• Create and maintain risk assessments for various operations.

• Stay updated on regulatory intelligence and industry standards.

3. Product Quality

• Perform material release and batch release. Provide Certificate of Analysis (CoA) and certificate of conformance (CoC).

• Receive, evaluate, investigate a product complaint and respond to the complainant.

• Propose and implement risk mitigation measures for incidents (eg product recalls, stop distribution).

• Evaluate product returns and the product disposition.

• Investigate cause of product shortage and propose remedy actions.

• Establish the stability study protocol and evaluate stability data.

• Conduct Product Quality Review (PQR).

4. Liaison with Health Authority

• Obtain and maintain HSA manufacturer license.

• Obtain and maintain HSA GMP certificate.

• Report product defects to HSA.

• Report planned product recall to HSA.

• Liaise with HSA on GMP-GDP inspections.

• Liaise with HSA on product sampling.

• Obtain and maintain Halal certification.

Qualifications

• Bachelor Degree or equivalent in Science-related field

• Minimum 5-7 years’ experience as a Quality Assurance, Quality Control or Quality Compliance personnel in the pharmaceutical or medical device industry

• Has problem solving and organizational skills

• Has a sense of ownership and accountability

• Able to work well with colleagues within the department and with other departments

What we offer

• Competitive salary and benefits package

• Opportunities for professional development and advancement

• A dynamic and collaborative work environment