KriGen Pharmaceuticals LLC,
800 Edwards Dr, Lillington,
NC 27546, USA
Job Description
Duties:
Active involvement in planning and strategy preparation for new products.
Sourcing of raw materials (API, Excipients) and Compendial Standards and impurities.
Guiding Scientists to conduct development trials to freeze the analytical method and to specification of dosage forms.
Analyzes pharmaceutical raw materials, process intermediates and finished product stability samples, following approved standard test methods and procedures.
Preparation, co-ordination and implementation of Standard Operating Procedures (SOP) and Memorandum of Agreement (MOA)
Document review of analytical development report, analytical validation report, standard operating procedure, technology transfer documents,
Calculates and interprets test results as per test methods and specifications.
Reviews Out-of-Specification (OOS)/ Out-of-Trend (OOT) test results and preparing the investigation report of the same.
Resolving query related to Development for Analytical Method
Operates, maintains, and calibrates equipment in assigned area
Education Requirement:
Bachelor’s Degree in Chemistry or closely related field such as Pharmacy
2
(Full Time)
Salary: $ 40,000 - $ 60,000
Salary:Candidate will get 10% to 20% rise on current package.
KriGen Pharmaceuticals LLC,
800 Edwards Dr, Lillington,
NC 27546, USA
Job Description
Responsibilities and Duties
Identify Internal Quality Observation and subsequently triggering CAPA, ChangeControl, and Incident through QMS with its compliance and its quarterly trend analysis.
To Prepare / Review of URS, DQ, RA, FAT, SAT, IQ, OQ and PQ of Equipment, System for Newly started Injection Division
To Review and compile cGMP related documents such as BMR, BPR, Protocol and report of executed activities as well as draft of the SOP, Protocol and report before finalizing.
To Review and compile equential logs, validation and qualification protocol and reports.
To monitoring and evaluation of Critical process parameter(CPP) and Critical Quality attributes (CQA) during routine production
To review Incidence Investigation report.
To Perform OOS investigation & OOT.
To do follow up with CFT for Timely effectively closure of QMS Elements.
To give observation and subsequently trigger CAPA and Incident & deviation.
To Handle CAPA and Risk Management and its documentation.
To do Representation of QMS document to the Auditor
Knowledge of Risk Assessment.
Required Experience, Skills and Qualifications
Must have minimum 3 to 7 years of experience in Injectable / Parenteral company having USFDA/other Regulatory approvals.
Must have directly faced minimum 2 regulatory audits, out of which one must be USFDA.
KriGen Pharmaceuticals LLC,
800 Edwards Dr, Lillington,
NC 27546, USA
Job Description
Job Summary
Required Product manager Technology Transfer for Injectable Plant. Responsible for execution of batches from small scale to large scale. Responsibilities and Duties
Prepares master batch records and protocols for the manufacture of development, stability, and process performance qualification batches. Translates development findings into manufacturing processes.
Ensures Tech Transfer interdisciplinary groups, assigns and coordinates the Tech Transfer specific tasks; identifies root cause of the technical problems as well as project team management until resolution.
Active involvement in planning and strategy preparation for new products.
Supports the departments with respect to scaling up processes, sourcing of raw materials (API, excipients) equipment and process validation, and manufacturing of development, stability, and process qualification batches.
Guiding scientists to conduct development trials to freeze the process and specifications of dosage forms.
Generate key documentation including the Product Development Report (PDR), Development Protocol, Gap Analysis that includes process design, Technology Transfer Master Plan/Scope, Technology Transfer Report, Project Timeline and Action Item lists.
Critical monitoring of product/process characteristics of development batches to develop a product that is scalable.
Review of literature, patent review and discussing patent related issue with IPR and strategy preparation for development.
Resolving technical problems related to Formulation and Development for Product Approval.
CMO site sourcing, evaluation and finalization.
Assesses manufacturing processes by risk analysis method(s) and uses results to design manufacturing processes.
Develops and executes necessary investigative studies to address product deviations and changes to a manufacturing process.
Qualifications and Skills
Doctor of Pharmacy (PharmD) or Master's or Bachelor's degree in Pharmacy
4
(Full Time)
Salary: $ 40,000 - $ 60,000
Salary:Candidate will get 10% to 20% rise on current package.
KriGen Pharmaceuticals LLC,
800 Edwards Dr, Lillington,
NC 27546, USA
Job Description
Job Duties / Responsibilities:
Conduct environmental monitoring within QC laboratory, manufacturing suites, Isolators, clean rooms, and fill/finish operations to support aseptic and non-aseptic operations.
Perform, coordinate various microbiological quality control tests of High Purity Water, EM, Raw materials, in-process materials, finished products, media fills.
Setup new microbiology laboratory to meet cGMP standards and various regulatory requirements FDA, MHRA, EU, and WHO.
Write, review, and approve SOP, specifications, Test Methods, Method Validation Protocols/reports.
Write, review, and approve User Requirement Specifications for equipment selection, procurement, and their calibration, qualification.
Write, review, and approve validation/qualification protocols, reports for various equipment, utilities, facility.
Support validation, qualification of new sterile fill finish facility, equipment, utilities, media fill, and sterilization.
Recognized as the Microbiology subject matter expert by exhibiting technical and theoretical understanding of microbiological methods
Sound knowledge of cGMP, FDA, MHRA, EU regulations
Assist with internal and external regulatory audits.
Assist with planning, preparation, performing a variety of routine and complex Quality Control tasks following cGMP regulations.
Coach and develop staff by providing an environment that encourages ongoing personal and professional development. Manage and ensure the setting of realistic goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.
Evaluate and approve technical or investigation reports
Review, evaluate and approve change records and trend reports
Design and implement cGMP systems to correct deficiencies and develop staff expertise
Education: Bachelor’s / Master's Degree in Microbiology, Biology or a closely related field
Work Experience: Minimum 5 years
5
(Full Type)
Salary: $90,000 - $105,000
Salary:Candidate will get 10% to 20% rise on current package.
KriGen Pharmaceuticals LLC,
800 Edwards Dr, Lillington,
NC 27546, USA
Job Duties / Responsibilities:
Create and manage quality documents, including Standard Operating Procedures, Batch Production Records, HACCP Plan, and associated records
Coordinate Quality, Compliance, and Safety training and coaching site-wide and provide guidance with compliance and regulatory topics
Perform and/or coordinate completion of: Environmental monitoring and documentation e.g. personal monitoring, air bioburden, temperatures, and particle counts
Collect environmental monitoring samples as necessary
Train new Quality Assurance staff
Record sterility testing results, aseptic technique qualifications, and media fill process validations
Review/approve routine change control requests as designated
Oversee control of product labeling/label accountability
Recommend and/or implement improvements in streamlining processes and procedures in the areas of compounding, validation, change control, laboratory, and risk assessments
Using incident and Corrective and Preventive Action (CAPA) activities and processes to drive quality improvements and respond to process and service issues
Lead root cause analysis and CAPA for audit observations, product complaints, product non-conformances, in-process deviations and CAPA
Develop improvements within the QC/QA department, including training, SOPs, etc.
Work closely with the Sr. Sterilization Microbiologist regarding all sterilization related activities.
Perform or assist with sterilization validations, as applicable.
Perform/support sterilization product adoptions and determine product testing requirements
Direct the investigation of excursions in manufacturing or other related operations. Resolve the cause, impact on product quality, disposition and corrective actions
Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures and perform final disposition of batch
Verify that product test results meet specification limits
Track vendor equipment calibration and maintenance records and assess for deviations
Enter test results or summaries into the monthly and quarterly Quality Assurance report template
Document results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions
Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification)
Job Requirements:
Education Requirements:
Bachelor’s degree in Microbiology, Biology, Pharmacy, or Closely Related
Qualifications:
Must have minimum 5 years of experience in Injectable/Parenteral Company having USFDA/Other Regulatory Approvals
Must have directly faced minimum 4 regulatory audits, out of which two must be USFDA
