Document Creation and Review:
Drafting and revising Standard Operating Procedures (SOPs) and test methods.
Preparing specifications for raw materials, in-process samples, and finished products.
Issuing and reviewing Certificates of Analysis (COAs).
Documenting results from various analyses, including raw material, finished product, and stability studies.
Quality Management Systems (QMS) Support:
Participating in the management and closure of change controls, deviations, and Corrective and Preventive Actions (CAPAs).
Maintaining records and reviewing analytical data to ensure compliance.
Regulatory Compliance:
Ensuring that all activities and documentation adhere to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other regulatory guidelines.
Staying updated on pharmacopeial standards and implementing them into internal documents.
Data Management and Trending:
Creating and maintaining master specifications and data in relevant systems.
Performing trending of water analysis, out-of-specification results, and other quality-related data.
Instrument and Equipment Management:
Preparing calibration schedules and overseeing their proper execution.
Reviewing daily and monthly calibration records for laboratory instruments.