Quality Assurance Packaging Line Inspector

Piramal Pharma•Bethlehem, PA

1d•Onsite

About The Position

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.

Requirements

Minimum of 2 years degree in science or technical field
3+ years of experience
Strong understanding of pharmaceutical cGMP, industry standards, and regulations
Strong verbal and written communication skills with the ability to interact across functions, departments, and seniority levels
Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems including SAP and TrackWise
Ability to explain problems, solutions and make recommendations
Ability to handle various urgent requests in a professional manner
Attention to details and organizational skills when handling all activities related to batch records
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

Responsibilities

Responsible for the overall product quality on the packaging line, approval of line clearance and documenting all activities on the packaging line in accordance with PCC procedures
Issuance of Master batch records, generation of Bill of Materials (BOMs) for packaging and assurance that all material/components used in the packaging run are in accordance with the appropriate BOM
Maintain, complete, review and control packaging batch records to assure appropriate completion and handling of record
Performance and accurate documentation of in process inspections and retain/ customer samples
Maintains appropriate control and labeling of finished goods materials leaving the packaging area (status of Finished Goods as Released, quarantined, etc.)
Assures appropriate usage, disposition and destruction of unused Packaging components, including cartons, labels and inserts
Performs special projects and assignments as indicated by Quality Management
Assist in maintenance and revision of procedures related to Quality Assurance activities on the packaging line
To communicate any issues affecting the packaging line during line clearance, line setup and during inspections
To provide oversight and assistance to the packaging team with any quality issues
To communicate any issues affecting manufacturing and packaging, safety concerns, personnel concerns to the appropriate managers and work with them to resolve any issues
To be an active Quality Assurance team member and work with the department on resolving all issues related to product quality
support overtime as needed