About this role
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description
Our client’s is seeking a highly motivated Sterile Manufacturing Scientific/Technical Writer job description which includes, but is not limited to: Key Responsibilities: Documentation and Compliance:
• Ensure compliance with cGMPs, SOPs, and GSK standards of documentation to support sterile manufacturing. • Participate and oversee the preparation of GMP/GLP documents such as Standard Operating Procedures, Production Forms, batch records, Logbooks, and Laboratory Notebooks. • Assist in the preparation of metrics and key KPIs for the area. • Support the daily activities of the area to ensure the manufacture of quality parenteral products for development and clinical needs. • Accountable for reporting and maintaining metrics as appropriate. Technical Writing and Review:
• Support the preparation, revision, and archiving of technical documents such as area rationales, templates, SOPs, equipment procedures, risk assessments, contamination control strategies etc. • Ensure zero instances of data falsification or data integrity issues by PPD staff. • Generate and report metrics for Sterile Ops led processes. Safety and Quality:
• Inspect work area for safety regulations and recommend improvements. • Identify and coordinate implementation of safety, quality, and business improvements. • Assist and contribute to GMP and safety self-inspection activities. Communication and Collaboration:
• Proactively communicate the status of critical compliance systems support and problem resolution. • Lead by example in working collaboratively and embracing GSK’s Code of Conduct. Support and Training:
• Provide technical support and participate as a Subject Matter Expert on GQP topics. Continuous Improvement:
• Apply knowledge and leverage continuous improvement activities to support adherence with industry regulations, Global Quality Policies, and business procedures. • Lead the identification and implementation of strategies to improve the qualities and efficiencies of Sterile Ops processes and systems. • Maintain strong systems/process understanding of current technologies and professional concepts.
Additional Responsibilities:
• Strong understanding and application of aseptic manufacturing principles to implement new technologies/processes to the Sterile pilot plant. • Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, good documentation and data integrity principles. • Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of Sterile Ops management. • Responsible for scheduling and planning work to meet priorities set by GSK, setting specific daily and weekly priorities to meet timelines, and recommending procedures and policies to supervision. • Employee may be asked to perform administrative tasks such as procedure revision, template revision, records filing, records archiving, and other tasks as needed. • Employee has computer skills including Word, Outlook, and ability to navigate simple website interfaces. • Employee must have good hygiene, practice good hand-washing behaviors, and be comfortable frequently using hand sanitizing agents. • Employee may be asked to work occasional overtime hours. • Must be a committed team player prepared to work in and embrace a team-based culture. • Identifies risks to business for consideration by management.
Education: Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a minimum of 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job. Preferred understanding of GMP manufacturing.