Sr. Mfg QA Specialist

Piramal Pharma Limited; Lexington, Northern (KY, KY); Hybrid; USD 75,000 - 105,000; Full time

Job summary

Piramal Pharma Limited in Lexington, KY, seeks a Sr. Manufacturing QA Specialist to ensure compliance with cGMP and FDA regulations across manufacturing, testing, warehousing and distribution of pharmaceutical products.

The role reports to QA Supervisor and requires strong technical writing, audit support, and ability to lead QA activities on the manufacturing floor, with collaboration across departments to resolve quality issues.

Qualifications

• Bachelor's degree in life sciences or related field, with preferred life sciences background.
• Minimum 3+ years in QA within pharmaceutical manufacturing or similar regulated environment.
• Strong knowledge of cGMP and FDA regulations; ability to read and follow procedures.

Responsibilities

• Provide QA oversight during manufacturing, testing, warehousing and distribution activities.
• Assist in audits and self-inspections, and act as liaison with client interactions.
• Review batch records and protocols; support issue identification and corrective actions.
• Prepare data summaries and contribute to process mapping and system analysis.
• Lead on-floor QA activities, product inspections and line clearances when needed.

Skills

QA oversight

cGMP compliance

FDA regulations

Technical writing

Audit support

Education

Bachelor's degree in life sciences

Tools

Microsoft Office

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.