HumanEdge has partnered with a Pharmaceutical Industry client to hire a Technical Writer for a long term contract opportunity.
The Technical Writer - Investigations ensures quality assurance and regulatory compliance throughout the investigation, deviation, and CAPA Management process while adhering to applicable regulatory statute and standards.
- To promote the safety, identity, strength, purity, and quality of the products while supporting the overall company business plan.
- Supports the Business Unit by providing necessary data, writing reports, and conducting research on various topics.
- Stays updated on best practices and quality trends and regulatory requirements.
- Writes clear, concise and thorough investigations for quality events using quality risk management principles.
- Writes clear, concise and thorough investigations for product complaints.
- Reviews and approves Out of Specification reports.
- Perform RCA using industry standards, such as FMEA, 5Whys, Fishbone diagram. Identify CAPA to remediate and reduce identified risks.
- Work with cross functional teams to perform RCA, identify failure modes and propose appropriate CAPA.
- Perform Risk Assessments to assess impact to product quality safety and efficacy.
- Manages CAPA and CAPA effectiveness processes.
- Works with cross functional groups to verify CAPA implementation, effectiveness and timeliness.
- Tracks and trends quality event and complaint metrics.
- Proactively identifies possible quality events and initiate steps to prevent identified events. Identifies opportunities for continuous improvement.
- Acts as a QA liaison in Client and internal project meetings.
- Reviews and approves laboratory deviations and investigations.
- Assists with development/writing of quality SOPs, documents and/or reports as needed.
- Provides support during regulatory inspections and client audits.
- Summarizes and trends quality events within Annual Product Reviews
- Other duties as assigned.
Experience & Skills Required
- Strong knowledge of cGMPs and experience in GMP processes and pharmaceutical document review to understand and guide process improvements
- Of particular importance understands quality systems
- Possesses some knowledge of project management tools and has some experience leading cross functional teams
- Communication- Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information
- Leadership- Exhibits confidence in self and others; Inspires and motivates others to perform well; Accountable for behaviors and their impact on others; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others
- Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals
- Ability to prioritize and respond to changing business demands
- Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions
- Critically evaluates quality systems to propose best practices
- Strong problem solving skills and analytical assessment for continuous improvement
- Able to critically think, assess problems and collaborate to come to an appropriate resolution
- Proactive and driver of continuous improvement operations.
- Applies risk management philosophy to business processes, decisions, and data Innovation
- Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention
- Applies risk management philosophy to business processes and decisions