EXPANSION MQA Specialist

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 65,000 - 90,000; Full time

Job summary

Piramal Pharma Solutions is seeking an EXPANSION MQA Specialist to join the Quality Assurance team in Lexington. The role focuses on in-process QA activities, environmental monitoring, audits, and QMS support per GMP and site SOPs.

The position reports to the Quality Supervisor and works night shifts, contributing to batch records review, GMP investigations, and data documentation. Strong regulatory knowledge and written communication are essential.

Qualifications

• Bachelor's degree in physical or biological sciences or related field.
• 1 year of QA or Environmental monitoring experience in pharmaceutical manufacturing.
• Experience with IPQA/EM, cGMP or FDA regulatory guidelines.
• Proficiency in Microsoft Office (Word, Excel, Outlook and Access).
• Strong written and verbal communication; detail oriented.

Responsibilities

• Acquire understanding of aseptic technique; maintain clean room discipline and cGMP compliance.
• Perform In-process QA activities, inspections, labeling and line clearances per SOPs.
• Review batch records and protocols; ensure timely batch disposition.
• Conduct environmental monitoring of cleanrooms (air and surfaces).
• Sample and test utilities including water, steam and gases.
• Document plate enumeration and testing results; assist in cleaning verification.
• Participate in audits and client interactions as needed by management.
• Maintain laboratory instrumentation and calibrations; track trend data.

Skills

Communication

Detail oriented

Technical writing

Education

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

Tools

Microsoft Office

Job description

Be the First to Apply Division Piramal Pharma Solutions Piramal 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

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.