What are the responsibilities and job description for the Manufacturing Quality Assurance Specialist position at Piramal Enterprises?
Manufacturing QA Specialist- Night shift
Business: Pharma Solutions
Department: Quality Assurance
Location: Lexington
Job Overview
The 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
Reports to QA Supervisor
Key Responsibilities
- Review executed batch records and executed protocols and work with departments to address and correct issues.
- 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
- 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, etc.
- Execute assigned training and development plan
Education Requirements
- High school education or equivalent
- Bachelor’s Degree in the physical or biological sciences or related scientific field preferred
Experience
- Previous experience performing quality related activities within a manufacturing environment, pharmaceutical manufacturing preferred
- Previous experience working within strict regulatory guidelines, cGMP or FDA preferred
Competencies
- Working 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
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
