Drug Regulatory Affair and Validation Specialist (Authorized Person)

Duties:

• Preparation of documentations for regulatory submissions (including new product submissions, change in particulars, tender submissions) to authorities
• Preparation of responses to post-submission queries by regulatory authorities
• Maintain centralized databases on regulatory activities and update accordingly; perform regular follow ups on assigned products and tasks according to business priorities.
• Ensure proper filing and records keepings for regulatory documentations.
• Product technical support
• Prepare and Execute Cleaning Validation, Transportation Verification and Process Validation in a timely and efficient manner
• Ensure assigned validation tasks are compliance with GMP requirements.
• Support Product Quality Review (PQR) data gathering related to Cleaning Validation, Transportation Verification and Process Validation, Internal Audit
  
• Assist in Deviation Investigation, Change Control and Corrective Action Preventive Action (CAPA).
• Work closely with various internal departments and distributors in maintenance of product supply continuity and ensuring regulatory compliance in Hong Kong and Macau.
• Assist in ensuring compliance to Corporate Standards, local and international regulatory requirements.
• Assist in training
  
• Ad hoc duties

Requirements:

• Degree holder or above in Pharmaceutical Studies or other science related discipline.
• Registered Pharmacist or HK Authorized Person in a pharmaceutical company is a MUST
• At least 3 years of relevant experience (supervisory level or above) in GMP pharmaceutical manufacturing and/or quality control in pharmaceutical manufacturer
• Hands-on GMP experience in pharmaceutical manufacturing industry will be a definite advantage
  
• Good command of English and Chinese

For Job Seekers, who prefer to directly sent your CV to us, our job seekers directly apply email address is posted in our company profile above.

Please kindly send your CV in WORD format ONLY with:

1. CURRENT and EXPECTED SALARY
2. AVAILABILITY
3. JOB TITLE in your EMAIL SUBJECT