Piramal Pharma Lifescience jobs as Quality and Compliance Specialist, in US
Welcome to Piramal Pharma Solutions
Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is a global leader in pharmaceutical research and contract manufacturing. We are committed to translating discoveries into commercial realities, ensuring high-quality products that meet regulatory standards.
Job Title: Quality and Compliance Specialist
Location: Riverview, MI, United States
Job Description:
Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility in Riverview, MI, is seeking a qualified Quality & Compliance Specialist (QA) to join our Quality Assurance (QA) team. This position will play a critical role in supporting the manufacturing operations of our facility to ensure compliance with regulatory requirements set forth by the USFDA and international authorities.
Key Responsibilities
- Review of batch production records
- Operations Support
- Administrative Duties
- Audits
- Reports/Document Management
- Quality Systems Support
- Metrics
- Risk Management
Education/Experience
- Bachelor’s degree in the physical or biological sciences or engineering with 1 or more years’ experience in pharmaceutical operations/quality or another GMP environment.
- Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance.
- Individuals without a degree but having at least 3-5 years’ experience in pharmaceutical operations, regulated life sciences, quality assurance, or an equivalent combination of Quality and technical education will also be considered.
- Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
- Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.
- Proficient in TrackWise, SAP and Master Control or experience working with document management and ERP systems.
Job Competencies
- Organizational and planning skills
- Strong communication skills
- Attention to detail
- Analytical and problem-solving skills
Time Required in Job to Reach Effective Performance
- Induction period: 3 months
- Time to reach performance effectiveness: 6 months
Job Conditions
- Physical Demands
- Work Environment
For more details, please review the original job notification.
Keywords: Quality and Compliance Specialist, Riverview Michigan, Compliance Specialist job, Pharmaceutical Operations, GMP Requirements
