|Basic Function and Responsibility:
Responsible for performing and leading Technical Service and Validation studies at G&W laboratories
Responsible for all aspects of validation activities, including writing protocols and reports, complying with Good Manufacturing Practices (CGMP), Standard Operating Procedures (SOP) and Food and Drug Administration (FDA) requirements.
Projects include: Alternate API/Excipient qualification, scale up/down, Submission batches, Technical Transfers, Process Improvement projects, Process Validation, Cleaning Validation, Water Systems Validation, Equipment Qualifications, Packaging Validation and other projects as necessary.
Takes a leadership role on Tech Services projects. Coordinates activities within and across departments. Coordinates project meetings as needed and prepares meeting minutes.
Prepares protocols, collects data, analyzes data and prepares final reports
Prepares, maintains and evaluates Cleaning Validation Matrix
Revises and improves the master batch record, Official Forms and Standard Operating Procedures
Prepares Change Controls and performs tasks associated with the CCR
Performs thorough document reviews and has an attention to detail
Researches Process history per APR system and recommends process improvement projects.
Aids Manufacturing and Packaging in troubleshooting, problem solving and product impact analysis.
Aids in investigation writing and customer complaint investigations.
Creates Batching and cleaning recipes for the Becomix and Unimix.
Other tasks as assigned by Technical Services management.
Aspects of Performance:
Possesses sound analytical problem-solving and documentation skills
Demonstrates ability to prioritize conflicting demands
Must be able to bend repeatedly and lift up to 50 lbs
Executes assigned tasks within established schedules
Writes and speaks clearly and concisely
Develops and maintains expertise through continuing professional education and training
Complies with Company policies, procedures, rules and regulations
Attention to detail
Strong communication skills
Understanding of Manufacturing processes
Must be fluent in Microsoft Word, Excel, Access, Project and Powerpoint
B.S. in Physical Science (Engineering, Chemistry, Pharmacy, etc.)
0-5 years of pharmaceutical experience
|G & W Labs|
State or Province