Quality Assurance Manager (GMP)

Health Hope Pharma Limited; Hong Kong; Vor Ort; HKD 600.000 - 1.200.000; Vollzeit

Zusammenfassung

Health Hope Pharma Limited in Hong Kong seeks a GMP Quality Assurance professional to support the quality management system and ensure compliance across manufacturing and testing activities.

You will manage deviations, CAPA, change control, OOS/OOT, and non-conformances, review records and COAs, and support regulatory readiness. Strong English documentation skills and experience with CDMOs are essential.

Qualifikationen

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Bioengineering, Chemistry, Life Sciences, Medical Devices or a related discipline.
• Three plus years of GMP quality assurance experience in pharma or related industry.
• Knowledge of deviation management, CAPA, change control, OOS, OOT, validation and quality risk management.
• Experience with CDMO and supplier quality management.
• Familiarity with FDA 21 CFR Parts 210-211, EU GMP or other international requirements.
• Understanding of medical device quality systems for drug-device products.
• Proficiency in English for technical review and communication.

Aufgaben

• Support the establishment, maintenance and continuous improvement of GMP quality management system.
• Manage deviations, CAPA, change control, OOS and OOT, non-conformances and quality complaints.
• Review batch manufacturing records, testing records, validation documents, COAs and quality agreements.
• Support R&D, technology transfer, process validation and manufacture of investigational products.
• Participate in qualification and auditing of CDMOs, contract testing labs and suppliers.
• Follow up on quality incidents and remediation activities involving external partners.
• Support quality management for drug-device products including syringes and delivery devices.
• Participate in device design changes, supplier changes, risk assessments and packaging validation.
• Support internal audits and readiness for regulatory inspections by authorities like NMPA, FDA and EMA.
• Regularly report significant quality risks and improvement recommendations to the CSO.

Kenntnisse

GMP quality assurance

Deviation management

CAPA

Change control

OOS/OOT

Validation

Quality risk management

CDMO and supplier quality

FDA 21 CFR Parts 210-211

ISO 13485 / QMSR knowledge

English documentation

Ausbildung

Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Bioengineering, Chemistry, Life Sciences or Medical Devices

Tools

eQMS

Jobbeschreibung

• Support the establishment, maintenance and continuous improvement of the GMP quality management system.
• Manage deviations, corrective and preventive actions (CAPA), change control, out-of-specification (OOS) and out-of-trend (OOT) results, non-conformances and quality complaints.
• Review batch manufacturing records, testing records, validation documents, certificates of analysis (COAs), product specifications and quality agreements.
• Support research and development, technology transfer, process validation and the manufacture of investigational medicinal products.
• Participate in the qualification and auditing of contract development and manufacturing organisations (CDMOs), contract testing laboratories and key suppliers.
• Follow up on quality incidents, remediation activities and CAPA involving external partners.
• Support quality management for syringes, microneedles, drug delivery devices and other drug-device combination products.
• Participate in device design changes, supplier changes, risk assessments, and packaging and transport validation.
• Support internal audits, supplier audits and readiness for regulatory inspections by authorities such as the NMPA, FDA and EMA.
• Regularly report significant quality risks, project progress and improvement recommendations to the CSO.

Requirements

• Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Bioengineering, Chemistry, Life Sciences, Medical Devices or a related discipline.
• At least three years of GMP quality assurance experience in the pharmaceutical or a related industry.
• Sound knowledge of deviation management, CAPA, change control, OOS, OOT, validation and quality risk management.
• Experience in CDMO and supplier quality management.
• Knowledge of FDA 21 CFR Parts 210 and 211, EU GMP or other international requirements.
• Understanding of medical device quality systems and quality requirements for drug-device combination products.
• Familiarity with ISO 13485, the FDA Quality Management System Regulation (QMSR) and 21 CFR Part 4 is preferred.
• Experience with syringes, microneedles, drug delivery devices, sterile devices or drug-device combination products is preferred.
• Good written English and reading comprehension skills, with the ability to review quality and technical documents in English.
• A meticulous approach to work, strong communication and coordination skills, and the ability to solve problems independently.
• Willingness to travel to CDMO facilities, testing laboratories and supplier sites.

Preferred Qualifications and Experience

• Experience in an innovative drug development company or a clinical-stage biopharmaceutical company.
• Experience with oral solid dosage forms, oncology medicines or ophthalmic products.
• Experience in technology transfer, process validation, supplier auditing or regulatory inspection support.
• Experience using electronic quality management systems (eQMS).
• CET-6 or an equivalent level of English proficiency, with strong listening, speaking, reading and writing skills and the ability to independently handle quality documentation and work-related communication in English.