Manufacturing Quality Assurance Specialist

Job Description

Business: Pharma Solutions

Department: Quality Assurance

Location: Lexington

Job Overview

The primary purpose of the role is to perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and QMS support according to Good Manufacturing Practices (GMP) and site specific Standard Operating Procedures (SOP).

Reporting Structure

This position reports to the Quality Assurance Supervisors

Shift

Night Shift

Key Responsibilities:

• Acquire an understanding of aseptic technique, continuously exhibit proper clean room behaviour, and adhere to cGMPs.
• Perform all In-process QA activities, inspection, labeling and packaging Line clearances following as per company SOP's.
• Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
• Perform environmental monitoring of classified cleanroom areas (Viable Surface/air, Non-Viable air)
• Sampling and lab testing of the utilities including water, steam, and compressed gases.
• Perform plate enumeration and documentation of the results.
• Assist in the performance and documentation for cleaning verification sample collection and analysis.
• Participates in audits and involve in onsite client interactions as needed by management.
• Maintain laboratory instrumentation required for testing including calibrations.
• Aide in the maintenance of environmental monitoring trend data to drive continuous improvements and identify trends.
• Participate in Microbiology material inventory control for EM media plates.
• Prepare and summarize data associate with site metrics, write, read, and revise SOP's QA and EM, technical reports.
• Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations per PPS QMS systems.
• Adhere to all applicable regulations, policies, and procedure for health, safety, environmental compliance and support the Quality management as needed basis.

QUALIFICATIONS:

• Bachelor's Degree in physical or biological sciences or related scientific field preferred
• 1 years of Quality assurance or Environmental monitoring experience performing quality related activities within a pharmaceutical manufacturing environment
• Must have previous experience working within QA Plant support (IPQA /EM), strict regulatory guidelines, cGMP or FDA
• Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
• 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

About Us

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.

About the Team

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.

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