DirecciónReponsabilities :
This includes, but is not limited to, the Quality System oversight and / or performance of the following activities :
- Author / Review Certification reports (ECMS)
- Supplier Quality verification as it pertains to material chain of custody (SCA)
- Deviation investigations, quality issue management and escalation (EQV, IMT)
- Maintain schedule adherence (Demand and Capacity) for all certification subprocesses
- Compendial requirements verification
- Change Control Management (EQV)
- SOP management
- LEAN initiatives to simplify and standardize processes (Lean Capability Individual Contributor)
- Quality Risk Assessment (QRA)
Key Accountabilities
- Collaborates with AZ Sites to achieve schedule adherence
- Facilitates process and system improvements via voice of customer
- Archiving certification documentation as required
- Set up of automated reporting of results process (through GQCLIMS / power Bi)
- Site Liaison contact for QC, PT&D, EQ, etc.
- Initiative and projects supporting certification program and interdependent global processes
- Regulatory Audit support
Supports Quality Management Systems
- Supplier Quality Management support
- Quality Control support
- Manages internal deviations in deviation system
- Manages global change controls
- Manages Risk assessments
- Manages Document Reviews and approvals
In addition to the above Key Accountabilities a Quality Manager is expected to include in their remit the following :
- LEAN strategies
- Demonstrated experience working cross-functionally and managing significant improvement initiatives (e.g., project management skills)
- Strong problem-solving skills
- Strong negotiating / influencing skills
Education, Qualifications, Skills and Experience
Essential
- Bachelor’s degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering
- Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment.
- Strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
- Excellent oral and written communication skills English and local language(s)
Specifically required essentials :
- Multi
- Ability to work independently under his / her own initiative.
- Ability to travel nationally and internationally as required approximately 10% of their time.
Date Posted
03-Jan-2024
Closing Date
03-Mar-2024
