EXPANSION MQA Specialist

Piramal Pharma Ltd; Lexington (KY); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Piramal Pharma Solutions in Lexington is seeking an EXPANSION MQA Specialist to perform in-process QA activities, environmental monitoring, audits, and QMS support in accordance with GMP and site SOPs.

The role reports to the Quality Supervisor and involves working night shifts with a focus on maintaining compliance, reviewing batch records, and contributing to continuous improvement of QA systems.

Qualifikationen

• Bachelor's degree in physical or biological sciences or related field.
• 1 year of QA or environmental monitoring experience in pharmaceutical manufacturing.
• Ability to understand regulatory requirements (cGMP, OSHA, FDA).
• Proficiency in MS Office applications.
• Effective written and verbal communication.

Aufgaben

• Perform In-process QA activities, environmental monitoring of facilities and utilities according to GMP and SOPs.
• Conduct audits and support QMS activities.
• Review batch records and protocols to meet disposition timelines.
• Perform environmental monitoring of cleanroom areas (air/ surfaces).
• Sample and test utilities (water, steam, compressed gases).
• Assist in cleaning verification sample collection and analysis.
• Participate in audits and client interactions as needed.
• Maintain laboratory instrumentation and calibration records.
• Document and summarize data for site metrics and QA/EM reports.
• Conduct GMP investigations including root cause analyses and risk assessments.

Kenntnisse

Detail oriented

Verbal and written communication

MS Office

Ausbildung

Bachelor's degree in physical or biological sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Microsoft Access

Jobbeschreibung

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