Corestaff Pte Ltd – QA Executive

QA Executive (Entry Level / West / 5D)

The leading pharmaceutical ophthalmic solutions manufacturer. Dedicated to providing sterile pharmaceutical and ophthalmologic solutions along every step, from prevention to delivery of care at every touchpoint, advancing wellness in hospitals, clinics and home-care sectors.

• 5 days work week
• $2200 - $3000
• Career Progression
• Training Provided

Responsibilities: 

• Assisting the QA Regulatory Manager in managing the Regulatory Inspection (FDA, SGS, HSA etc)
• Participate and assist in the implementation and maintenance of the management system in accordance with relevant quality standards and regulatory requirements (cGMP, FDA 21 CFR, EU MDD, ISO 13485 and ISO 9001)
• Participate and assist in the development of QA strategies, recommendations for continual improvement, quality planning in conjunction with the needs of the company, for each product range
• Assist and coordinate with the regulatory authorities about acceptable claims, wordings, performance data and other information requisite for marketing the products
• Participate in company vigilance system including product recall activity, assisting in assessing the recall class of the product recall and assuring that regulatory components of the product recall are understood and complied
• Provides supervisory support to the QA department and ensure SOP & workflow are adhered from time to time
• Participate and assist for establishment verification and implementation of all company procedures to comply with cGMP and ISO requirement.
• Assist in employee cGMP training such as employee orientation, quality awareness, and job training.

Requirements:

• Degree in Science (Biology, Chemistry, Pharmaceutical) or any relevant field 
• Knowledge of the cGMP, US FDA QSR and 21 CFR, EU MDD, ISO standards such as ISO 9001, ISO 13485 is preferable
• Knowledge of basic technology employed by the business such as BFS technology, API aseptic manufacturing is preferable
• No experience needed (training will be provided) 
• Self-motivated to keep up with the current practices

Wong Xi Wai (Aries)

Registration Number: R2095933
EA License No: 18C9027