M&S-Batch Release Lead-Beijing (Pharmaceutical Quality Assurance)

Location: Beijing, China; onsite role

Company

hirify.global is a global healthcare company developing and delivering medicines and healthcare solutions.

What you will do

• Oversee batch release processes, batch record reviews, and approval of associated documentation.
• Ensure batch release activities comply with GMP, company standards, and local and international regulations.
• Coordinate Quality Control, production, and other teams to release lots on time according to flow controller priorities.
• Investigate and resolve batch release issues and deviations, including product-specific temperature excursion evaluations.
• Approve SOPs, quality events, deviations, laboratory investigations, and batch disposition documentation; update the digital release tool.
• Participate in audits, inspections, Quality Alert and Product Alert meetings, global CoP/CoE activities, complaint investigations, and change assessments for Amaryl manufactured at the Hangzhou site.

Requirements

• At least 5 years of QA experience in the pharmaceutical industry, focused on batch release processes and QA management.
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles.
• Ability to meticulously review batch records and documentation for accuracy and regulatory compliance.
• Experience analyzing batch release performance metrics and identifying improvement opportunities.
• Ability to efficiently investigate and resolve batch release issues and deviations.
• Ability to follow company HSE policies, procedures, and technical action plans.

Culture & Benefits

• Supportive, future-focused environment centered on healthcare innovation.
• Career growth opportunities through promotions and international or lateral moves.
• Rewards package recognizing individual contribution and impact.
• Healthcare, prevention, and wellness benefits for employees and families.
• At least 14 weeks of gender-neutral parental leave.