Company

PiramalSee more

addressAddressSellersville, PA
type Form of workFull-Time
CategoryManufacturing

Job description

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients 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 like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. www.piramalpharmasolutions.com

 The  QA Specialist supports the activities of the QA group by performing the release of commercial product including performing manufacturing investigations.  Functions as a department representative for internal/external projects

Responsibilities for Internal Candidates

  • Supports the activities of the QA Group by performing the release of commercial product.
  • Completion and the documentation of manufacturing deviations. Significant responsibility with minimal supervision.
  • Field alert and recall investigations are included in the scope of investigations. This function includes ensuring all pertinent information is compiled, reviewed and approved prior to any product disposition. 
  • Functions as the department representative in terms of tasks, projects and operations. Functions as the point person for internal/external projects.
  • Supports QA review and approval of SOPs, deviations  and change control.
  • Assists in evaluating technical issues and recommends solutions as appropriate. Provides technical assistance to the organization in own areas of expertise.
  • Communicates frequently with internal personnel and all levels of management. 
  • Participates and assists with debriefings, investigations with internal and external representatives.
  • Develops and executes departmental training as needed.
  • Participates in the identification and implementation of continuous improvement opportunities.
  • Other tasks as assigned due to business and departmental needs.
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.
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.
Refer code: 9000782. Piramal - The previous day - 2024-04-13 04:20

Piramal

Sellersville, PA
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