Plans, coordinates, and leads quality assurance program associated with creation and maintenance of GMP related documents to ensure consistency with established standards, by performing the following duties personally or through subordinate employees.

Responsibilities:

• Maintains an effective quality document control system. Re-engineers the current system into a more efficient, user friendly system. Ensure SOPs and MBRs were routed in a timely manner.


• Oversees/develops syllabus of quality system training courses offered at Impax.


• Manages the PIT 7 (Process Improvement Team 7 – Training) activities.


• Helps to transfer Quality System to Impax Taiwan.


• Establishes and maintains filing systems for batch records, SQARs, and other related documents. Maintains order in the documentation room.


• Oversees the SOP administration system (number assignment, typing, master and copy files maintenance, electronic files maintenance, distribution).


• Oversees the master batch records administration system (initiation, # assignment, typing, current and obsolete master files maintenance, electronic files maintenance, distribution).


• Maintains logbooks for process validation protocol numbers, cleaning validation protocol numbers, etc.


• Maintains logbook for change control forms; files completed forms.


• Provides training to new hires.


• Writes, reviews, approves company GMP-related policies and SOPs.


• Investigates GMP-related or product problems; writes investigation reports.


• Develops new approaches to solve problems identified and recommends steps for improvement.


• Performs special projects assigned by QA management.


• Keeps abreast of cGMPs and working knowledge of government and industry quality assurance codes and standards.


• Support IMPAX Lab’s Quality System.


• Oversees the training program for all departments.


• Write the training program description and update as necessary.


• Oversees/develops the training matrix for each job classification with each department head. Training matrix includes tasks to be performed and the corresponding SOPs.


• Oversees/develops and maintains a central computerized training database.


• Oversees/maintains training documentation file for each individual employee. Retrieve files for individual employees as requested.


• Oversees/Organizes and conducts training sessions as needed.


• Other duties as assigned.


• Supervisory Responsibilities include oversight of QA Document Processor, QA Associate and Training Coordinator.

Requirements:

• BA/BS, with 3-5 years work experience in manufacturing environment (pharmaceutical industry preferred).


• At least 1 year supervisory experience.


• Proficiency in English report writing.


• Good writing skills for reports, memos, and proposals.


• Good verbal communication and listening skills.


• Must be able to make oral presentations.


• Must have the ability to relate and work well with people.


• Able to handle multiple tasks.


• Working knowledge of computers (Word, Excel, Access, etc.).


• Proficiency in Excel, Excel graphs, and data analysis.


• Knowledge/experience in GMPs or regulatory environment.