EXPANSION MQA Specialist

Piramal Pharma Limited; Lexington (VA); On-site; GBP 41,000 - 56,000; Full time

Job summary

Piramal Pharma Solutions in Lexington is seeking an Expansion MQA Specialist to lead in-process QA activities, environmental monitoring, and GMP-compliant investigations. You will collaborate with Quality Assurance and Operations to ensure data integrity and batch compliance.

The role requires a Bachelor’s degree in physical or biological sciences and hands-on QA or environmental monitoring experience in pharma.

Qualifications

• Bachelor’s degree in physical or biological sciences or related field.
• 1 year of QA or Environmental monitoring experience in pharma manufacturing.
• Experience with IPQA/EM and cGMP or FDA regulatory guidelines preferred.

Responsibilities

• Perform in-process QA activities and inspections.
• Conduct environmental monitoring of cleanrooms and utilities.
• Review batch records and ensure timely disposition per SOPs.
• Assist in GMP investigations including root cause analyses and risk assessments.
• Maintain calibration and operation of laboratory instruments.
• Participate in audits and client interactions as needed.

Skills

Aseptic technique

cGMP compliance

Environmental monitoring

QA documentation

Lab testing

Data analysis

Technical writing

Communication skills

Education

BSc in physical or biological sciences

Tools

MS Office

Laboratory instrumentation

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 MQA Specialist

Job Description

Business: Pharma Solutions

Department: Quality Assurance

Location: Lexington

Job Overview

Reporting to the Quality Supervisor, the primary purpose of the role is to perform In-process Process QA activities, the 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 Supervisor.

Shift

Nights

Key Responsibilities

• Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
• Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP's.
• Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
• Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
• Sampling and lab testing of the utilities including water, steam, and compressed gases.
• Perform plate enumeration and documentation of the results.
• Assist in the performance and documentation for cleaning verification sample collection and analysis.
• Participates in audits and involve in onsite client interactions as needed by management.
• Maintain laboratory instrumentation required for testing including calibrations.
• Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
• Participate in Microbiology material inventory control for EM media plates.
• Prepare and summarize data associate with site metrics, write, read, and revise SOP's QA and EM, technical reports.
• Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
• Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.

Qualifications

• Bachelor's Degree in physical or biological sciences or related scientific field preferred.
• 1 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