Be the First to Apply
Division
Piramal Pharma Solutions
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.
For more details, please visit: www.piramalpharmasolutions.com
Job Title
QC Analyst
Job Description
To execute defined and trained Quality Control department tests for the release of raw materials, in process products, bulk drug substance, final products and stability products according to defined procedures and protocols and according with best cGMP work practices, Quality standards and metrics.
Key Roles/Responsibilities
- Perform batch disposition and stability activities proactively and timely, including quality control testing and reporting of raw materials, in‑process, bulk drug substance, final products and stability products in accordance with GMP and regulatory requirements.
- Perform stability study programme activities, storage of in‑process and final product samples, and retention sample management.
- Serve as system owner of QC equipment, assisting in equipment periodic reviews, monitoring, and maintaining calibration status within the QC department.
- Own and account for deviations, investigations, and laboratory investigations, ensuring timely completion of documents.
- Prepare and update SOPs, instructions, protocols, and other QC documentation.
- Check and review data complying with data integrity requirements.
- Actively contribute to department and site audit readiness, including continuous improvement initiatives.
- Calibrate QC equipment and instruments, and inform relevant personnel of calibration status.
- Maintain QC information systems.
- Maintain technical knowledge and understanding of relevant regulatory requirements for GMP, safety, and environmental policies.
- Assist in investigation of quality incidents and other problem‑solving forums, completing QMS documentation in a timely manner.
- Attend internal and external scientific and technical meetings and conferences as appropriate.
- Carry out general equipment and laboratory maintenance and housekeeping.
- Provide cover for other departments within the organization as required.
- Undertake any other duties as requested by the QC Manager in accordance with company requirements.
Competencies
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
Be the First to Apply
Division
Piramal Pharma Solutions
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.
For more details, please visit: www.piramalpharmasolutions.com
Job Title
QC Analyst
Job Description
To execute defined and trained Quality Control department tests for the release of raw materials, in process products, bulk drug substance, final products and stability products according to defined procedures and protocols and according with best cGMP work practices, Quality standards and metrics.
Key Roles/Responsibilities
- Perform batch disposition and stability activities proactively and timely, including quality control testing and reporting of raw materials, in‑process, bulk drug substance, final products and stability products in accordance with GMP and regulatory requirements.
- Perform stability study programme activities, storage of in‑process and final product samples, and retention sample management.
- Serve as system owner of QC equipment, assisting in equipment periodic reviews, monitoring, and maintaining calibration status within the QC department.
- Own and account for deviations, investigations, and laboratory investigations, ensuring timely completion of documents.
- Prepare and update SOPs, instructions, protocols, and other QC documentation.
- Check and review data complying with data integrity requirements.
- Actively contribute to department and site audit readiness, including continuous improvement initiatives.
- Calibrate QC equipment and instruments, and inform relevant personnel of calibration status.
- Maintain QC information systems.
- Maintain technical knowledge and understanding of relevant regulatory requirements for GMP, safety, and environmental policies.
- Assist in investigation of quality incidents and other problem‑solving forums, completing QMS documentation in a timely manner.
- Attend internal and external scientific and technical meetings and conferences as appropriate.
- Carry out general equipment and laboratory maintenance and housekeeping.
- Provide cover for other departments within the organization as required.
- Undertake any other duties as requested by the QC Manager in accordance with company requirements.
Competencies
- Attention to detail
- Reliability
- Effective communication
- Understanding of scientific and technical processes
#J-18808-Ljbffr…