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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
Executive - TSD
Job Description
Executive - TSD
Job Summary**
Responsible for providing technical support and documentation for PPL Pharma Inc.'s products and processes within the Technical Services Department (TSD). This role ensures compliance with regulatory standards and contributes to the overall efficiency of pharmaceutical operations.
Job Responsibilities**
- Develop, revise, and maintain technical documentation, including batch records, Standard Operating Procedures (SOPs), protocols, and reports for various pharmaceutical manufacturing processes.
- Provide technical support for manufacturing operations, troubleshooting process deviations, and implementing corrective and preventive actions (CAPAs).
- Participate in process validation activities, including authoring protocols and reports, and executing validation runs.
- Assist in the investigation of product quality issues, deviations, and customer complaints, identifying root causes and proposing effective solutions.
- Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, and Research & Development, to ensure seamless project execution and regulatory compliance.
- Support the implementation of new technologies and processes, ensuring proper documentation and training.
- Stay updated with industry trends, regulatory requirements (e.g., GMP, ICH guidelines), and best practices in pharmaceutical manufacturing and technical services.
- Conduct data analysis and generate reports to support process improvements and decision-making.
Job Qualifications**
- Bachelor's degree in Chemical Engineering, or a related scientific discipline.
- Minimum of 2-4 years of experience in a technical services, manufacturing, or quality assurance role within the pharmaceutical industry.
- Strong understanding of Good Manufacturing Practices (GMP) and other relevant regulatory guidelines (e.g., ICH).
- Proven ability to author clear, concise, and accurate technical documentation.
- Experience with process validation, deviation investigation, and CAPA management.
- Excellent analytical, problem-solving, and communication skills (written and verbal).
- Ability to work independently and as part of a team in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
