EXPANSION Sr. Mfg QA Specialist

Piramal Pharma Limited; Lexington (VA); On-site; GBP 68,000 - 90,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Manufacturing QA Specialist for the Quality Assurance department in Lexington. The role focuses on in-process QA activities, environmental monitoring, and documentation to ensure GMP compliance.

You will lead complex investigations, oversee EM programs, and support audits, CAPA, and continuous improvement while working a nights shift.

Qualifications

• Bachelor's degree in physical or biological sciences or related field is preferred.
• 4+ years of QA or Environmental monitoring experience in pharma manufacturing.
• Experience with QA Plant support (IPQA/EM) and regulatory guidelines (cGMP/Fda) is required.
• Proficiency in MS Office applications (Word, Excel, Outlook, Access).
• Strong written and verbal communication; detail oriented; able to follow regulatory requirements.

Responsibilities

• Perform in-process QA activities, environmental monitoring of facilities and utilities.
• Lead GMP investigations, root-cause analysis, CAPA development and risk assessments.
• Review batch records, protocols, and support documentation for batch disposition.
• Provide oversight of EM activities for classified areas and sampling/testing of site utilities.
• Prepare, review and revise SOPs, reports, and QA documentation; support audits.

Skills

Aseptic processing knowledge

cGMP compliance

Environmental Monitoring

QA documentation

Communication skills

Education

Bachelor's degree in physical or biological sciences or related field

Tools

Microsoft Office

SAP

Job description

Division

Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title

EXPANSION Sr. Mfg QA SpecialistJob Description

Business: Pharma Solutions

Department: Quality Assurance (QA)

Location: Lexington

Job Overview

Reporting to the Quality Assurance Supervisor, the primary purpose of the Senior Manufacturing QA Specialist role is to perform in-process QA activities, environmental monitoring of facilities and utility systems, audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).

Reporting Structure

This position reports to the Quality Assurance Supervisor.

Shift

Nights

Key Responsibilities

• Demonstrate strong knowledge of aseptic processing, cleanroom behavior, and cGMP requirements and consistently maintain compliance with site procedures.
• Perform and provide oversight of in-process QA activities, including inspections, labeling, packaging, and line clearances in accordance with approved SOPs.
• Review executed batch records, protocols, and supporting documentation to support timely and compliant batch disposition.
• Perform and provide technical oversight of Environmental Monitoring (EM) activities for classified areas, including viable surface/air and non-viable air monitoring.
• Perform sampling and testing of site utilities, including water, steam, and compressed gases, as applicable.
• Perform microbiological testing, including plate enumeration, result review, and accurate documentation.
• Support cleaning verification activities, including sample collection, testing, review, and documentation.
• Maintain laboratory instrumentation and ensure required calibration and qualification activities are completed.
• Evaluate EM and quality trends, identify potential adverse trends, and initiate appropriate risk-based actions and continuous improvement initiatives.
• Support microbiology material and EM media inventory management to ensure testing readiness and compliance.
• Prepare, review, and revise SOPs, technical reports, risk assessments, site metrics, and other QA/EM documentation.
• Lead complex GMP investigations, including root-cause analysis, product impact assessments, risk assessments, and CAPA development in accordance with the site QMS.
• Serve as a Senior MQA Subject Matter Expert (SME) for Environmental Monitoring, Contamination Control, Sterility Assurance, and complex manufacturing quality issues.
• Support the development, implementation, and continuous improvement of the site's Environmental Monitoring and Contamination Control programs, including associated risk assessments and technical reports.
• Provide senior QA oversight and coordination of quality activities supporting batch disposition and product release.
• Serve as an MQA representative during client, internal, and regulatory audits, including FDA and MHRA inspections, and support responses to audit observations.
• Provide technical guidance, coaching, and mentoring to MQA Specialists and serve as an escalation point for complex quality and compliance matters.
• Lead and support quality and process improvement initiatives involving QA processes, QMS performance, EM, contamination control, and manufacturing quality.
• Perform material disposition and associated activities in SAP, ensuring accurate documentation and timely disposition.
• Participate in client interactions, investigations, technical discussions, and other site quality activities as required by management.
• Ensure compliance with all applicable cGMP, regulatory, health, safety, environmental, and company requirements.

Qualifications

• Bachelor's degree in physical or biological sciences or related scientific field preferred.
• 4+ years of Quality assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment
• Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA
• Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
• Proficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)
• Demonstrated ability to effectively communicate both verbally and in writing
• Ability to read and follow written instructions
• Detail oriented
• Understanding of sterile manufacturing preferred
• Technical writing skills preferred