Sr. Mfg QA Specialist

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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.

Shift

Nights

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