Validation Specialist
6 days ago
We are seeking a highly motivated and detail-oriented Validation Specialist with at least 2 years of experience in the transfer of solid products, packaging processes validation, and cleaning validation within the pharmaceutical manufacturing industry. The ideal candidate will have a strong understanding of regulatory requirements and quality standards, including cGMP (current Good Manufacturing Practices) and FDA guidelines.
Key Responsibilities:
Transfer of Solid Products:
- Plan and execute the transfer of solid dosage products between manufacturing sites or within departments.
- Coordinate with cross-functional teams to ensure seamless product transfers.
- Perform risk assessments and ensure compliance with regulatory requirements during the transfer process.
Validation of Packaging Processes:
- Develop and implement validation protocols for packaging processes.
- Conduct validation/qualification of packaging equipment.
- Ensure packaging systems maintain product integrity and compliance with stability studies and storage conditions.
Validation of Cleaning Procedures:
- Validate cleaning procedures for equipment used in the production of solid dosage forms to ensure compliance with regulatory and safety standards.
- Develop cleaning validation protocols, including sampling techniques, acceptance criteria, and analytical methods.
- Ensure proper documentation and reporting for all validation activities.
Compliance & Documentation:
- Maintain thorough and accurate documentation of all validation activities according to cGMP and regulatory requirements.
- Prepare validation reports and provide input into regulatory submissions as needed.
- Ensure compliance with FDA, EMA, and other relevant regulatory authorities.
Qualifications:
- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, or a related field.
- 2+ years of experience in the pharmaceutical manufacturing industry, specifically in solid product transfer, packaging process validation, and cleaning validation.
- In-depth knowledge of cGMP, FDA regulations, and industry guidelines related to pharmaceutical production and validation.
- Hands-on experience with validation protocols (IQ, OQ, PQ) and statistical analysis of validation data.
- Strong problem-solving skills, with attention to detail and the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills for documentation and cross-functional collaboration.
Preferred Skills:
- Experience with solid oral dosage forms such as tablets or capsules.
- Proficiency in validation software or tools.
- Knowledge of Lean Manufacturing or Six Sigma principles.
- Familiarity with equipment such as tablet presses, blister packaging machines, and cleaning validation analytical techniques.
-
Quality Assurance Specialist
1 week ago
Puerto Rico, United States ProQualityNetwork Full timeJob Title: Specialist QAWe are seeking a highly skilled Specialist QA to support our client's Quality Assurance program under minimal supervision. This is an exciting opportunity to contribute to the assurance of product quality in a dynamic environment.Key Responsibilities:Review and approve product Master Plans (MPs).Approve process validation protocols...
-
Travel Nurse RN Long Term Acute Care Specialist
4 weeks ago
Rio Rico, Arizona, United States Vibra Travels Full timeJob DetailsJob Title: Travel Nurse RN Long Term Acute Care SpecialistJob Type: Travel NursingLocation: NationwideDuration: 13 weeksShift: 12 hours, nightsHours per Week: 36 hoursAbout the JobVibra Travels is seeking a skilled Travel Nurse RN Long Term Acute Care Specialist to join our team. As a Traveling Registered Nurse for Long Term Acute Care, you will...
-
Rico, Colorado, United States Austin Major Group Full timeJob SummaryAustin Major Group is seeking a skilled Interventional Cardiologist to join our team for a part-time opportunity. The position involves Cath lab coverage and includes on-call responsibilities.Key Responsibilities:Provide high-quality patient care in a fast-paced environmentCollaborate with a renowned healthcare team to deliver exceptional patient...
-
Puerto Rico Health Client Specialist I
3 weeks ago
Rico, United States Alight Solutions Full timeAmazing Opportunity and Great Place to Work! Are you a fast learner who is fascinated by Client interactions?Our Story At Alight, we believe a company’s success starts with its people. At our core, we Champion People, help our colleagues Grow with Purpose and true to our name we encourage colleagues to “Be Alight.” Our Values Champion People – be...
-
Travel Nurse ICU Specialist
3 weeks ago
Rio Rico, Arizona, United States Vibra Travels Full timeTravel ICU Nurse Job OpportunityVibra Travels is seeking a skilled Travel ICU Nurse to join our team. As a travel nurse, you will have the opportunity to work in various ICU settings across the country, providing high-quality patient care and advancing your nursing career.Job DetailsJob Title: Travel ICU NurseLocation: Rio Rico, ArizonaDuration: 13...
-
Equipment Sales Professional
1 day ago
Aragüés del Puerto, Huesca, United States Benco Dental Full timeEquipment Sales Specialist OpportunityBenco Dental, a leading dental distributor, is seeking an experienced Equipment Sales Specialist to join our team. As a key member of our sales team, you will be responsible for driving equipment sales and providing exceptional customer service to our clients.Key Responsibilities:Develop and maintain strong relationships...
-
Building Maintenance Specialist
3 days ago
Aragüés del Puerto, Huesca, United States Colliers Full timeAbout the RoleWe are seeking a skilled Building Engineer to join our team at Colliers. As a key member of our facilities team, you will be responsible for ensuring the maintenance systems are running efficiently to ensure the safety of our clients and their properties.Key ResponsibilitiesMaintain and check daily operating logs for air conditioning, fan...
-
Window Cleaning Specialist
4 days ago
Aragüés del Puerto, Huesca, United States Fish Window Cleaning Full timeJob SummaryFish Window Cleaning is seeking a courteous and self-motivated individual to join our team as an Outside Customer Service Representative. As a key contact at our locations, you will be responsible for providing exceptional customer service, completing window cleaning tasks, and ensuring customer satisfaction.ResponsibilitiesProvide excellent...
