Sr. Mfg QA Specialist

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 70,000 - 100,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Sr. Manufacturing QA Specialist based in Lexington to ensure compliance during manufacturing, testing, warehousing and distribution of pharmaceutical products.

The role reports to the QA Supervisor and involves reviewing records, supporting process improvements, and representing QA in client interactions and audits.

Qualifications

• Must have 3+ years of QA experience in pharmaceutical manufacturing.
• Thorough knowledge of cGMP and FDA regulations.
• Proficient with MS Office applications (Word, Excel, Outlook).

Responsibilities

• Write, read and revise technical reports.
• Review batch records and protocols; coordinate issue resolution.
• Assist QA leadership with process mapping and system analysis.
• Provide QA oversight during manufacturing, testing, warehousing, and distribution.
• Participate in audits, self-inspections, and client meetings; support training.

Skills

QA Experience

cGMP / FDA

MS Office

Communication

Detail-Oriented

Sterile Manufacturing

Technical Writing

Education

High School Diploma

Bachelor’s in Science

Job description

Company Overview

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: Sr. Mfg QA Specialist

Job Description

Business: Pharma Solutions Department: Quality Assurance Location: Lexington

Job Overview Reporting to the Quality Assurance Supervisor, the SR. Manufacturing QA Specialist helps to ensures compliance with regulations and standard operating procedures by performing quality oversight activities during the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.

Reporting Structure

This position reports to the Quality Assurance Supervisor.

Key Responsibilities

• Write, read and revise technical reports
• Train and support staff regarding QA responsibilities
• Review executed batch records and executed protocols and work with departments to address and correct issues
• Prepare and summarize data associated with site metrics.
• Assist QA Leadership in process mapping and system analysis
• Review pest control, calibration, HEPA certification, logbooks, and work order documentation.
• Execute "on the floor" activities (line clearances, product inspection, interim problem solving, etc.)
• Provide QA oversight and perform walkthroughs of manufacturing areas
• Participates in audits and self-inspections.
• Represents Quality during client interactions (meetings, audits, investigations, etc.)
• Execute assigned training and development plan
• Troubleshooting systemic GMP issues
• Provides leadership on projects and within systems that interface with other departments.
• Provides SME support, review and approval during meetings, audits, investigations, technical reports

Qualifications

• High school education or equivalent required
• Bachelor's Degree in physical or biological sciences or related scientific field preferred
• 3+ years of QA experience performing quality related activities within a pharmaceutical manufacturing environment
• Must have previous experience working within strict regulatory guidelines, cGMP or FDA
• Thorough knowledge of cGMP and applicable FDA regulations
• 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

Company Information

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.

Equal Employment Opportunity

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.