Job Purpose: To support the Edison Packaging Site by performing cGMP required QA Auditing and Documentation functions while following cGMP and corporate policies to achieve company goals and initiatives. Perform quality review of and Packaging Records.
Description of KEY responsibilities: Audit all Packaging Batch Records at the Edison Site. Sever as a contact person for Quality Assurance Training. Oversee the maintenance and update of the department tracking systems. Audits records to ensure compliance with the approved master packaging records. Audits records to ensure compliance with 21CFRpart211 subpart F (Production and Process Control). Evaluates quality impact of process deviations. Reviews and approves release status of packaging product. Identities the need for investigations for deviations. Develop control documents pertinent to Quality Assurance (QA) activities and functions, as well as other procedures if deemed necessary. Serve as a backup for the QA Documentation Specialist. Additional projects with increase responsibility as instructed.
Skills and specific knowledge required Essential: · Current knowledge of Documentation, Change Control and cGMP’s in the pharmaceuticals industry.
· Ability to interact with all levels of the organization.
· Ability to foster and work in a team environment.
· Experience using Microsoft Office applications, Trackwise, Qumas, QAD
· Must be well organized, detail-oriented, and experienced in working with minimal supervision.
· Possess excellent verbal and written communication skills.
· Thorough knowledge of cGMPs.
· Essential: BA/BS
3+ year experience in Quality Assurance function with a solid dose pharmaceutical manufacturer or packaging
Actavis - 17 months ago
As its name implies, the Actavis U.S. is the US manufacturing and marketing unit of global generics firm Actavis. The company makes some 150...