Quality Assurance Compliance Specialist - Bethlehem, United States - Piramal Enterprises

Piramal Enterprises

Verified Company

Bethlehem, United States

6 hours ago

Posted by:

Mark Lane

beBee recruiter

Essential Duties and Responsibilities

Packaging Batch Records: Reviews final batch records on paper and electronically, documents batch errors from various departments, tracks, and issues reports.
Manufacturing Batch Records: issues batch records to production, electronically review production batch records, file and archive all the completed physical records.
Review lab data on paper/electronically for inclusion on C of A
Responsible for certificate of acceptance (C of A) generation for Bulk and Finished drug product, coordination of finished batch status tracking
Releases product within SAP and generates reports as needed
Reviews calibration sheets.
Supports the quality document archive system
Assist in the activities related to document control when needed
Act as a backup to other QA associates in his/her absence
Performs and supports internal audits and regulatory agency audits as needed
Performs special projects as directed by Quality Assurance management
Trains new employees in the department on the various tasks
Supports launch of new products in auditing/ understanding new processes as needed
Assist with reviews and investigations for Deviations
Assist with and/or conduct APRs
Assist with and/or conduct the updating of CRNs
Produce logbooks as requested
Supports RA requests relative to filings and submissions
Support Packaging Line Inspector including coverage as needed Assist with and/or conduct BOM and MBR updates

Key Competencies (knowledge, skills and abilities every person must possess to be successful)

Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
Excellent verbal and written communication skills
Creative and able to present various solutions
Energetic, enthusiastic and motivational disposition
Maintain confidentiality
Coaching skills