Planet Pharma
Job Description
Summary:
Position may perform the following: documentation, analytical assessment, or data gathering. The primary responsibility of this position is for support of qualification documentation filing, preparation or any responsibility surrounding data collection. Other department tasks may involve thermocouple assembly / calibration, data collection, system updates and other tasks as assigned.
Preferred excellent written and verbal communication skills, and ability to maintain cGMP compliance in accordance with worldwide guidance sources.
Job Responsibilities:
• Collects current equipment documentation to fill gaps or identify missing information. Working with Validation Engineers and quality assurance document control to implement necessary improvements. These may include modifications to existing documents, or collection and filing of current documents.
• Supports validation protocols for data collection, or creating documents, as assigned.
• Maintains compliance with regulatory agency guidance and company procedures.
• Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use
• Supports on-going system requalification and continuous improvement activities governed by change management processes
Skills:
• Possess an understanding of documentation organization, and ideally in a GMP environment
• Must have excellent verbal and written communication skills, attention to detail, and problem solving skills.
• Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc.
• Desirable to also have some basic mechanical skills.
• Preferred understanding of statistical analysis tools and/ or analytical methods.
Education/Experience:
• BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 0 - 2 years pharmaceutical manufacturing experience.
Pay ranges between $20-24.60/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Summary:
Position may perform the following: documentation, analytical assessment, or data gathering. The primary responsibility of this position is for support of qualification documentation filing, preparation or any responsibility surrounding data collection. Other department tasks may involve thermocouple assembly / calibration, data collection, system updates and other tasks as assigned.
Preferred excellent written and verbal communication skills, and ability to maintain cGMP compliance in accordance with worldwide guidance sources.
Job Responsibilities:
• Collects current equipment documentation to fill gaps or identify missing information. Working with Validation Engineers and quality assurance document control to implement necessary improvements. These may include modifications to existing documents, or collection and filing of current documents.
• Supports validation protocols for data collection, or creating documents, as assigned.
• Maintains compliance with regulatory agency guidance and company procedures.
• Assists with execution of equipment validation studies to include protocol execution, data analysis up to including control system administration such as software backups and system updates.
• Programs and operates department analytical instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Drafts commissioning and qualification protocols to sufficiently demonstrate the process is designed and fit for the intended use
• Supports on-going system requalification and continuous improvement activities governed by change management processes
Skills:
• Possess an understanding of documentation organization, and ideally in a GMP environment
• Must have excellent verbal and written communication skills, attention to detail, and problem solving skills.
• Must be experienced with Microsoft Office tools, i.e. Word, Excel, etc.
• Desirable to also have some basic mechanical skills.
• Preferred understanding of statistical analysis tools and/ or analytical methods.
Education/Experience:
• BS/BA Degree in science, engineering, manufacturing technology or closely related field, or equivalent experience in a manufacturing facility.
• 0 - 2 years pharmaceutical manufacturing experience.
Pay ranges between $20-24.60/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.