Responsible for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance
Job Summary
Responsible for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance.
Ensures alignment across subject matter experts and stakeholders to implement analytical changes globally and coordinates resolution of misaligned change control priorities across operating units.
Maintains a broad based knowledge of cGMP's, company Policies, Procedures and Guidelines, regulatory requirements, compendial requirements, etc. pertinent to the manufacturing, personal safety, control, testing and documentation of pharmaceutical products.
Matching Summary
Responsible for providing functional support for Analytical Standards and Analytical change control activities for new products, in-line products, packaging, outsourcing, divestitures and compendial compliance.
Skills & Requirements
Must-have
Analytical Standards and Change Control
cGMP Compliance
Regulatory Compliance
Quality Operations
Technical Writing
Nice-to-have
Creative thinking and resourcefulness
Professional objectivity and integrity
Consensus building
Continuous improvement mindset
Key Requirements
BS degree in life sciences, engineering or related discipline
10 years applied professional work experience
Experience in Change Control, Laboratory Operations and/or Quality operations with laboratory oversight