Quality Assurance Inspector Job at Piramal Pharma Solutions, Sellersville, PA

azBqdS83ZFFsQyt5RU11WmswdWZlbGE3aGc9PQ==
  • Piramal Pharma Solutions
  • Sellersville, PA

Job Description

Quality Operations Inspector -I

Position Summary

The Quality Assurance Inspector is responsible for providing on-the-floor quality oversight and support to ensure the compliance of manufacturing, packaging, labeling, and distribution operations with Piramal Standard Operating Procedures (SOPs) and applicable regulatory requirements. This includes adherence to Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity principles, and FDA regulations. The inspector plays a critical role in maintaining product quality, safety, efficacy, and regulatory compliance across operations.

Key Responsibilities

  • Issue batch records in alignment with the production schedule to support timely manufacturing activities and Perform potency calculations as applicable.
  • Conduct line clearance and batch readiness assessments, including verification of concurrent documentation, equipment status, and preventive maintenance records.
  • Review and evaluate Environmental Monitoring (EM) data for compliance with internal standards and regulatory requirements.
  • Perform BMS alarms review, acknowledgement and evaluate quality impact. Escalate critical alarms to Management.
  • Perform quality oversight for water system releases used in operations.
  • Perform raw material Sampling and AQL inspection of finished products.
  • Review equipment logbooks and executed batch records to ensure adherence to GDP, GMP, and Data Integrity standards.
  • Scan reviewed batch records and upload to share point.
  • Prepare batch records and perform first release of batches.
  • Perform Raw material reconciliation and investigation.
  • Review and approve Calibration activities in ProCal.
  • Perform QA review and approval of non-routine workorders in SAP.
  • Draft, revise, and review Quality Assurance SOPs and deviation reports to ensure clarity, accuracy, and regulatory alignment.
  • Conduct weekly quality surveillance activities, including facility inspections, environmental monitoring checks, and audits of equipment maintenance and GMP practices to support continuous audit readiness.
  • Complete all assigned training on SOPs and job-related tasks in a timely manner.
  • Stay current with industry trends, updates to regulatory requirements, and emerging quality standards.
  • Perform all other activities as assigned by Manager

Experience:

  • 1–3+ years of experience in pharmaceutical quality assurance, regulatory affairs, or GMP auditing.
  • Prior experience in providing on-the-floor quality oversight and conducting inspections or working in a regulated pharmaceutical environment preferred.

Skills:

  • In-depth knowledge of GMP, GDP, GLP, and relevant international regulations (FDA, EMA).
  • Strong analytical, attention to detail investigative, and problem-solving skills.
  • Excellent communication (written and verbal) and interpersonal skills.
  • Proficiency in MS Office and quality management systems (QMS).
  • Ability to travel to facilities for inspections (as required).

Job Tags

Similar Jobs

Hamilton Jewelers

Executive Assistant Job at Hamilton Jewelers

 ...The Senior Executive Assistant serves as assistant, partner, confidant, gatekeeper, and representative of the owners and operators of Hamilton. More than a standard Executive Assistant role, this individual is tasked with staying one step ahead of the schedule and day-... 

Sunbelt Controls

Systems Software Engineer Job at Sunbelt Controls

 ...Sunbelt Controls , a leading provider of Building Automation System (BAS) solutions across the Western U.S. In this role, youll develop and program databases, create custom graphics, and integrate control systems for smart buildings. Youll also support project... 

Pryor Associates Executive Search

Property & Casualty Actuary - PR13022 Job at Pryor Associates Executive Search

 ...Property & Casualty Actuary opening in NJ or GA. Play key role in pricing E&S business involving General Liability, Commercial Auto, Workers Compensation, and Commercial Property; perform profitability analysis; design, build, and maintain pricing models and monitoring... 

Michaels Stores

Retail Store Manager Job at Michaels Stores

 ...Michaels.com and Michaels.ca .The Michaels Companies, Inc. also owns Artistree, a manufacturer of custom and specialty framing merchandise. Founded in 1973 and headquartered in Irving, Texas, Michaels is the best place for all things creative. For more information,... 

First Integrity Title Company

Front Desk Representative Job at First Integrity Title Company

 ...supplies on a weekly basis Assist with group inbox data entry, assigning emails, other duties as needed Qualifications: One year of administrative/reception work is required High School Diploma or equivalent Bilingual (Spanish) highly sought ...