Senior Quality Assurance Specialist - Sellersville, United States - Piramal Group

Description

Job Description Perform and manage the internal audit program including documentation and performing audits Lead all aspects of customer audits including initial audit scheduling, audit preparation, and audit response reports.

Lead all aspects of contract lab and supplier audits including initial audit scheduling, audit preparation, and audit response reports and follow-up.

Lead dialogue to align and collaborate with customers regarding quality agreements Provide status reports for internal activities to drive continuous improvement including but not limited to the following metrics:
change controls, CAPAs, etc. Evaluate data looking for trends and possible future concerns. Maintain current required training for respective activities performed as part of this role. Perform training to Quality department on the tasks associated with this role as required.

Leads and Supports departmental and customer projects and/or assignments as indicated by Quality Management including CAPAs and change control improvement projects.

Drive timelines to assure due dates are met. Biennial Document Review

• Review of pertinent procedures, work instructions, and forms for accuracy during the periodic review period.

Lead and support the teams during deviation investigations.

Monitor department specific procedures, work instructions, forms, etc to assure that they are accurate and specific to the actual processes.

Implement any required revisions to assure compliance. Implement and support the change control process and support change control needs opened by the teams Support technical service projects and protocols Provide guidance and assistance to other QA Specialists with input into their performanceQualifications Minimum Education Qualification Bachelor degree or higher in relevant scientific quality assurance/technical field and 5 years' experience in a Manufacturing environment, QA, Quality Systems, and/or Compliance experience in a cGMP/FDA regulated environment Certifications None Functional or Technical Skills Ability to organize time and drive project tasks for multiple areas (major projects and daily functions)

Good written, verbal and interpersonal communication skills Basic computer skills such as Microsoft Office Minimum Experience (in Years) 5+ years experience Key Interactions:

Internal Nature or purpose of interaction QC Change controls, CAPAs, investigations, calibrations Operations CAPAs, investigations QA team Change controls, CAPAs, investigations, calibrations, metrics, QTAs Technical Services Projects, protocols Research and Development New Products/projects Facility Customer and Regulatory Audits External System Implementation Partners Vendors Third Party Vendors Regulatory AgenciesAbout UsIn 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 TeamPiramal 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.