Piramal Group
Senior Material Release Quality Assurance Specialist
Piramal Group, Lexington, Kentucky, us, 40598
Job Description
Business: Formulation Services
Department: Quality Assurance (QA)
Location: Lexington
Job Overview
The Senior Material Release Quality Assurance Specialist reviews executed batch records to ensure cGMP compliance, and works with internal stakeholders to correct any issues.
Reporting Structure
Manufacturing QA Manager
Key ResponsibilitiesReview executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.Assist in review, release of materials, components used in planning and batch manufacturing.Prepare and summarize data associate with site metrics ,write, read, and revise technical reports.Must have QA core experience , and have the ability to train and support staff regarding QA responsibilities as needed.Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations.Adhere to all applicable regulations, policies, and procedure for health, safety and environmental compliance.Execute the assigned training and development plan.Troubleshoot systemic GMP issuesProvide leadership on projects and within systems that interface with other departments.Provides SME support, review and approval during meetings, audits, investigations, technical reports, etc.Education Requirements
Bachelor's Degree in physical or biological sciences or related scientific field preferred.Experience
3+ years of QA experience performing quality related activities within a pharmaceutical manufacturing environmentMust have previous experience working within QA Plant support (IPQA), strict regulatory guidelines, cGMP or FDACompetencies
Thorough knowledge of cGMP and applicable FDA regulationsProficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)Demonstrated ability to effectively communicate both verbally and in writingAbility to read and follow written instructionsDetail orientedUnderstanding of sterile manufacturing preferredTechnical 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.
Business: Formulation Services
Department: Quality Assurance (QA)
Location: Lexington
Job Overview
The Senior Material Release Quality Assurance Specialist reviews executed batch records to ensure cGMP compliance, and works with internal stakeholders to correct any issues.
Reporting Structure
Manufacturing QA Manager
Key ResponsibilitiesReview executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.Assist in review, release of materials, components used in planning and batch manufacturing.Prepare and summarize data associate with site metrics ,write, read, and revise technical reports.Must have QA core experience , and have the ability to train and support staff regarding QA responsibilities as needed.Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations.Adhere to all applicable regulations, policies, and procedure for health, safety and environmental compliance.Execute the assigned training and development plan.Troubleshoot systemic GMP issuesProvide leadership on projects and within systems that interface with other departments.Provides SME support, review and approval during meetings, audits, investigations, technical reports, etc.Education Requirements
Bachelor's Degree in physical or biological sciences or related scientific field preferred.Experience
3+ years of QA experience performing quality related activities within a pharmaceutical manufacturing environmentMust have previous experience working within QA Plant support (IPQA), strict regulatory guidelines, cGMP or FDACompetencies
Thorough knowledge of cGMP and applicable FDA regulationsProficiency in the Microsoft Office applications (Word, Excel, Outlook and Access)Demonstrated ability to effectively communicate both verbally and in writingAbility to read and follow written instructionsDetail orientedUnderstanding of sterile manufacturing preferredTechnical 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.