EXPANSION Sr. Mfg QA Specialist

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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: LexingtonJob 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