Manager, Quality Assurance

Your Responsibilities

The Quality Assurance Manager is responsible for operations related Quality Assurance activities including; the manufacturing floor quality oversight, GMP documentation, batch record review and batch release.

Your Tasks

• Oversee and support implementation of electronic document control modules (Master Control) and  ERP system (SAP)
• GMP compliance improvements
• Writing new and revising current standard operating procedures (SOPs), specifications, etc.
• Auditing Production, Materials Management, and Quality Control functions
• Writing internal audit reports
• Support customer & regulatory audits. Responding to audit observations
• Reviewing all GMP documentation, including BPRs, SOPs, Specifications, Protocol, and Reports
• Reviewing trending data, Change Controls, Deviations, and CAPA’s
• Problem resolutions with GMP systems

Your Profile

• Bachelor’s Degree in Life Science related field, Chemistry, Biochemistry, Biology etc.
• Minimum of 5 years’ experience in a GMP/regulated industry
• Minimum of 3 years in QA management position
• Experience in GMP manufacturing environment, Quality Assurance, Quality Control
• Experience with 21 CFR Parts 110, 111, 210, 211, ICH Q7
• Experience with GMP document control
• Experience in both internal and external auditing
• Ability to work with regulatory agencies
• Strong supervisory skills and technical writing skills
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one’s time
• Communicate effectively and ability to function well in a team environment

We Offer

  You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

   looking for a new challenge and want to join a motivated team in an internationally renowned company,

   you should seize this opportunity.