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Piramal Group · 5 months ago

Senior Quality Assurance Compliance Specialist

3950 Schelden Circle, Bethlehem, PA, 18017, US

Full-time

Onsite

Senior Level

5+ years exp

Piramal Group is a critical care company located in Bethlehem, PA, seeking a Senior Quality Assurance Compliance Specialist. This role involves overseeing daily quality activities to ensure compliance with internal procedures and regulatory requirements, managing documentation, and supporting regulatory audits.

BiotechnologyHealth CareMedical

Responsibilities

Responsible for the review, approval, and disposition of finished product for the site and final CoA signature

Facilitates client project management as required ensuring 'quality on time and in full'

Coordinates the investigation and closure of non-conformances ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed

Leads or participates in focused deviation cross-functional investigations, improvement projects

Reviews and approves laboratory investigations in a timely manner and ensures appropriate root cause is identified

Provides assistance to other QA associates and assist with department trainings

Provides support to QA management during regulatory audits

Reviews BOMs, inspection plans, pallet patterns, calibration records and SOPs

Performs internal audits and assist in writing reports for audits

Maintains and revises procedures related to the quality assurance activities. Supports Annual Product Review (APR) reports by collecting batch record data, creating and maintaining data bases

Maintain the vendor complaint process

Maintain, monitor and provide trend analysis of DIs, LIs, CAPAs, customer complaints and change controls

Performs special projects and/or assignments as indicated by Quality Management

Oversee and review of Obsolete material destruction

Perform Quality inspections on packaging line as needed

Maintain supplier approval program

Support/Maintain site Document Control System

Review, approve and close out Document Change Requests

Tracking of changes using DCC spreadsheet and supporting actions through closure

Maintain original documentation archive and Archival of documents offsite

Printing of new and revised documents, Issuance of forms, logbooks

Review documentation submitted for routing in eDMS for proper formatting and accuracy

Load documents into an electronic Documentation Management System (eDMS)

Route documents for approval in the eDMS

Recall documentation for audits in a timely manner

Performs external audits and assist in writing reports for audits

Responsible for maintenance and revision procedures related to document control

Qualification

Pharmaceutical cGMPQuality computer systemsComputer system validationData analysisRegulatory complianceCustomer serviceCritical ThinkingVerbal communicationWritten communicationAttention to detailOrganizational skills

Required

Bachelor's degree in relevant scientific quality assurance / technical field

5+ 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

Expert level user for Quality computer systems

Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based systems

Thorough understanding of computer system validation and GAMP requirements

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

Energetic, enthusiastic, and motivated disposition

Attention to detail with strong organizational skills

Ability to explain problems, solutions and make recommendations, and the ability to manage various urgent requests in a professional manner

Ability to analyze data/trends to make sound regulatory interpretation while preparing metrics and reports

The ability to drive projects in relation to implementation of new workflows and updates to new systems

Company

Piramal Group

Glassdoor3.8

- Offices in over 30 countries - Brand presence in over 100 global markets - Team of over 10,000 people from 21 diverse nationalities Piramal Group is a global business conglomerate with diverse interests in Pharma, Financial Services, and Real Estate.

Founded in 1984

Mumbai, Maharashtra, IND

10001+ employees