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Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title
Quality Assurance Compliance Specialist
Job Description
Support GMP activities within the Bethlehem plant with an emphasis on reviewing records and lab reports for the release of drug product. Also responsible for contributing to maintaining Documentation activities and Documentation Control coverage, assisting with QC testing reviews and monitoring of manufacturing and packaging processes. Responsible for various day to day activities in the Quality Assurance areas. This is a 2nd shift position*
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