Quality Assurance Compliance Specialist

2 months ago

Bethlehem, United States Piramal Enterprises Full time

**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

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