Quality Assurance Packaging Line Inspector

Piramal Critical Care, Inc.; Bethlehem (Northampton County); On-site; USD 50,000 - 85,000; Full time

Job summary

Piramal Critical Care, Inc. seeks a Quality Assurance Packaging Line Inspector to provide on-line quality presence, perform line clearances, and authorize packaging runs. The role ensures proper disposition of printed components and accurate documentation per PCC procedures.

The ideal candidate has 3+ years in pharmaceutical QA, strong knowledge of cGMP, and proficiency with SAP/TrackWise, Excel, Outlook. This on-site role supports manufacturing operations and may require overtime.

Qualifications

• Minimum of 2 years degree in science or technical field.
• 3+ years of experience in pharmaceutical manufacturing or quality assurance.
• 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 SAP and TrackWise.

Responsibilities

• Perform start up inspections, line clearance and authorize start of runs on the packaging line.
• Issue Master batch records and generate BOMs for packaging; ensure materials align with BOM.
• Maintain, review, and control packaging batch records for proper handling.
• Execute in-process inspections and retain/customer samples with accurate documentation.
• Control labeling and disposition of finished goods leaving the packaging area.
• Communicate issues affecting packaging line and manufacturing to management for resolution.
• Support overtime as needed and assist quality management with procedures updates.

Skills

Critical Thinking

Customer service

Verbal & written communication

Creative problem solving

Energetic & motivational

Confidentiality

Coaching skills

Education

2-year degree in science or technical field

Tools

SAP

TrackWise

Excel

Job description

Be the First to Apply 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/

Quality Assurance Packaging Line Inspector

Job Description

The purpose of this role is to provide a quality presence on the packaging line, perform start up inspections, line clearance and authorize start of runs and other packaging activities. To perform quality inspection on the line and assures appropriate disposition and destruction of printed components.

• 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

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

Education/Experience

• 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

Physical Demands: Reporting to this position: N/A Travel: N/A General Oversight and Direction: Receives moderate to limited supervision working from objectives set by Manager. Employee organizes and carries out most assignments in accordance with standard practices, instructions, or previous training. Employee handles some situations independently.

Equal Employment Opportunity

Piramal Critical Care is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all associates and applicants without regard to age, sex, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disabled veteran, or Vietnam Era Veteran Status. Americans with Disabilities Act Applicants as well as employees who are, or become, disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.

Employee Job Responsibilities You are expected to follow all policies, procedures, and guidelines, conducting yourself in ways that protect the interests and safety of all employees and the company. The above statements reflect the general duties and responsibilities considered necessary to perform the essential functions of the job. This document should not be considered a fully detailed description of all the work requirements of the position. Piramal Critical Care may change the specific job duties with or without prior notice based on the needs of the organization.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.