QA Release Specialist / Delegated QP

JOB PURPOSE:

This position will provide support for and be directly responsible for a range of Quality Assurance/Qualified Person functions. This position will contribute to ensure that performance of manufacturing, packaging operations and drug product contract manufacturing organizations (CMOs) and product quality conforms to established cGMPs to ensure lasting customer satisfaction. This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.

MAIN DUTIES:

• Review of batch records for accuracy and completeness
• Review and approve all Master Batch Records used in manufacturing and packaging operations
• Disposition and release of product manufactured and/or packaged on site or by 3rd Party Manufacturers & New Product Introduction Products
• Collaborate in the execution of cGMP-training program.
• Prepare and Participate in the GMP audit program (internal and supplier audits)
• Perform Quality Assurance activities associated with: Change control, Deviations, CAPA and Customer Complaints
• Support the preparation/approval of the Product Quality Review reports
• Provide support to operational and functional groups to handle all situations that may adversely impact quality
• Provide support to global projects as requested.

CANDIDATE REQUIREMENT (competencies/work experiences):

The successful candidate will have knowledge, skills & experience gained in a pharmaceutical industry. 

• University degree in Pharmacy and further knowledge in GMP regulation
• Experience as Qualified Person
• Minimum of 3 years’ experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements.
• Previous experience using SAP and ability with IT tools and experience in Microsoft office
• Fluid in the communications (both written and spoken) in English
• Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal organisational complexity and ambiguity
• Quality mindset, ability to detect errors and propose improvements.