What are the responsibilities and job description for the Technical Writer position at Piramal Group?
Job Overview
The Technical Writer (Deviations and Investigations) supports plant Operations in writing, leading, and managing detailed investigations. This role will perform fact finding, assessment and determination of root cause (RCA), generate CAPAs and coordinate cross-functional teams. The Technical Writer is also responsible for generating and tracking performance metrics. A high level of aptitude for cGMP pharmaceutical manufacturing/packaging processes is required.
Key Stakeholders: Internal
Manufacturing, Packaging, Engineering, Planning, R&D, QC, QA, PM
Key Stakeholders: External
Clients, Vendors, Third Party Companies, Regulatory Agencies
Reporting Structure
Reports to Site Operations Leadership
Experience
Minimum of 2 years of deviation investigation or change control management experience within a GMP environment.
Competencies
- Knowledge of drug product manufacturing from formulation through the final package.
- Working knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with EU regulations. Self-motivated, organized and systematic
- Expertise in analytical techniques
- Proficient in technical writing
- Sound knowledge of GLP and key QMS systems
- Proficient in Microsoft Office Suites (Teams, Excel, PowerPoint, Visio, Word, SharePoint, etc.) in addition to experience working within shared work environments.
- Exhibits confidence, high emotional IQ, and strong interpersonal, written and oral communication skills
- Shows resiliency and flexibility in the face of challenges and adheres to project/plan timeframes
- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
Key Roles/Responsibilities
- Coordinate and conduct technical writing activities, partnering directly with internal and external stakeholders.
- Conduct investigations, procedural exceptions and nonconforming events.
- Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations.
- Document investigations results.
- Develop, implement, manage and track effectiveness of CAPA’s
- Flexible to support direction and activity when a deviation occurs on the off-shifts.
- Utilize trend data to incorporate into deviation investigations.
- Ensure accurate investigation schedules are maintained and communicated to management. Deliver notifications and status updates to management.
- Adhere to all company guidelines, SOPs and ensure required compliance training is up to date.
- Ensure work is performed in compliance with current GMP / GLP’s as required by regulatory and Company directives
The Technical Writer (Deviations and Investigations) supports plant Operations in writing, leading, and managing detailed investigations. This role will perform fact finding, assessment and determination of root cause (RCA), generate CAPAs and coordinate cross-functional teams. The Technical Writer is also responsible for generating and tracking performance metrics. A high level of aptitude for cGMP pharmaceutical manufacturing/packaging processes is required.
Key Stakeholders: Internal
Manufacturing, Packaging, Engineering, Planning, R&D, QC, QA, PM
Key Stakeholders: External
Clients, Vendors, Third Party Companies, Regulatory Agencies
Reporting Structure
Reports to Site Operations Leadership
Experience
Minimum of 2 years of deviation investigation or change control management experience within a GMP environment.
Competencies
- Knowledge of drug product manufacturing from formulation through the final package.
- Working knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with EU regulations. Self-motivated, organized and systematic
- Expertise in analytical techniques
- Proficient in technical writing
- Sound knowledge of GLP and key QMS systems
- Proficient in Microsoft Office Suites (Teams, Excel, PowerPoint, Visio, Word, SharePoint, etc.) in addition to experience working within shared work environments.
- Exhibits confidence, high emotional IQ, and strong interpersonal, written and oral communication skills
- Shows resiliency and flexibility in the face of challenges and adheres to project/plan timeframes
- Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective.
Key Roles/Responsibilities
- Coordinate and conduct technical writing activities, partnering directly with internal and external stakeholders.
- Conduct investigations, procedural exceptions and nonconforming events.
- Ensure root cause, corrective action preventative action (CAPA), and product impact are thoroughly addressed in investigations.
- Document investigations results.
- Develop, implement, manage and track effectiveness of CAPA’s
- Flexible to support direction and activity when a deviation occurs on the off-shifts.
- Utilize trend data to incorporate into deviation investigations.
- Ensure accurate investigation schedules are maintained and communicated to management. Deliver notifications and status updates to management.
- Adhere to all company guidelines, SOPs and ensure required compliance training is up to date.
- Ensure work is performed in compliance with current GMP / GLP’s as required by regulatory and Company directives
