Quality Assurance Manager (Medical Industry)

Job Purpose:

Responsible for establishing, managing and improving quality management system of organization to support warehouse process, distribution process and others processes which related to product quality and process quality to meet all applied standards and regulations such as GSDP(GDP), Pharmacovigilance and GMP/HACCP. To ensure quality system of contract manufacturer organizations that comply current PIC/s GMP as well as quality of finished product that meet approved specification according to drug license.

 Key Responsibilities:-

• Contribution to the development and implementation of best practice quality vision, strategy, policies, process and procedures to aid and improve quality operational performance.

• Contribute to new business initiatives and projects and review and communicate the impact on quality activities.

• Accountable for budget and policy recommendations in short and medium-term planning.

• Manage Quality Control related activities regarding product release and QMS system, document control system. Ensure that products and processes conform to specifications and regulation requirements.

• Monitor all operations that affect quality of product and distribution service to meet the needs of customer requirements and external certification bodies.

• Contribution to information and analysis to quality plans and reviews: preparation and complete action plans; implementing regulations, quality and customer requirements/ standards; identifying and resolving problems; completing audits; determining system improvements; implementing changes such as registered artwork to comply with registration specification.

• Develop quality assurance plans by conducting risk assessments; identifying critical control points and preventive measures; establish monitoring procedures, corrective actions, and verification procedures.

• Designating responsible personnel for GDP compliance.

• Maintain and improve product and service quality by completing company, standards, system, compliance, and surveillance audits, investigating customer complaints and oversee deficiencies.

• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, recalls, corrective actions.

• Train others in all aspects of the quality system and application of quality procedures

• Conduct supplier quality audit

• Responsible for receiving any information related to Vigilance issues.

• Work collaboratively, negotiate and engage with CMOs to facilitate delivery and compliance with the quality strategy

• Liaise with CMOs to resolve quality issues

• Review and monitor all QC reports from CMOs and ensure compliance

Qualifications:-

• Bachelor’s degree or higher in Pharmaceutical Science     

• Over 5 years’ experience in pharmaceutical industry, 2-3 years of leadership and management  experience in Quality functions.

• Excellence listening with attention to details, written & verbal communication skill.

• Must have an understanding of manufacturing operations, quality systems, and regulatory and cGMP expectations. Must have demonstrated ability to anticipate and resolve problems with minimum negative impact on production, quality, quantity, and cost.

• Strong organizational skills and the ability to take initiative for assigned projects.

• Strong analytical skills and ability to work independently and making sounds decision.

• Strong interpersonal skills in the areas of verbal and written communication, telephone courtesy and professionalism.

• Ability to prioritize and handle several projects concurrently, Self-motivated and have ability to take ownership of her/his responsibilities.

• Quality Management System regarding ISO9001, ISO13485, GMP/ HACCP, GDP, and/ or any other International Standards related Healthcare Products.

• Having Presentation, networking, and communication skills, fluent English communication.

PHC is  looking for a great confident candidate who has a passion to win to join our team.   We offer a competitive remuneration package for the right candidate. If you believe you are qualified for the above positions, please send a detailed resume in English stating the position you are interested in and your current and expected salary, together with your recent photograph to

Pacific Healthcare (Thailand) Co., Ltd.,

People and Culture Department

1320 CYAM Park Building, Unit B 01, 1st and 2nd Floor, Rama 3 Road, Chongnonsee, Yannawa, Bangkok  10120

E-mail: [email protected]

Website: www.phc.co.th

Only successful applications will be contacted.