Sr. Mfg QA Specialist

Piramal Pharma Ltd•Lexington, KY

3d•Onsite

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. They serve clients through a globally integrated network of facilities in North America, Europe and Asia. This enables them 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. They also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Their capability as an integrated service provider & experience with various technologies enables them to serve Innovator and Generic companies worldwide. This role helps to ensure compliance with regulations and standard operating procedures by performing quality oversight activities during the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products.

Requirements

High school education or equivalent required
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

Nice To Haves

Bachelor's Degree in physical or biological sciences or related scientific field preferred
Understanding of sterile manufacturing preferred
Technical writing skills preferred

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