|
|
|
|
 |
If this is a scam, MLM, or Home Based "Opportunity" then Mark as SPAM
|
 |
Thank you for helping! This job will be reviewed by us shortly. Undo
|
| Employer Name: RISING PHARMA HOLDINGS INC |
SpiderID: 13774099 |
| Location: East Brunswick, New Jersey |
Date Posted: 6/20/2024 |
| Wage: |
Category: Medical/Health |
| Job Code: |
|
Job Description:
Mfg. QA Specialist is needed to perform the following duties:
Expertise in project planning and execution up to commercialization of products to be specific, Liquid & Lyophilized vials, Ampoules, PFS, BFS, Ophthalmic products.
MQA Manufacturing Quality Assurance:
Batch release certification, Verify the cGMP/GDP compliance, avoid the data integrity.
Handling of deviations & change proposals related to the shop floor issues and relevant CAPAs.
Approval and compliance of change control, deviation, CAPA, QRM, Impact assessment, qualification & validation documents.
MFR, MPR, BMR, BPR, and Approval & compliance of quality and operations SOPs, In-process Quality Control records.
Media fill related documents, APQRs and Trends various NVPC.
Process Validation protocols and reports.
Media fills batches summary & reports.
Exhibits batches, cleaning validation batches.
Monitoring the execution of preventive maintenance of critical equipment and utilities.
Handling of software systems like., LIMS, ERP, and QMS & Process Pad for daily transactions related to in-process and batch releases.
Providing support during the Regulatory Audits and Internal Quality Audits. Involving in the Quality Risk assessments related to the shop floor.
Providing SOP and GMP training for all New/ Existing employees.
Participating in the brainstorming sessions and investigations to identify the root causes for the identified nonconformances and Market Complaints related to shop floor.
Involving in the Quality Risk assessments related to the shop floor.
Ensuring the implementation of CAPAs triggered through various quality elements and regulatory audits.
Reviewing the change proposals related to the shop floor (i.e., Manufacturing and Packing activity).
Preparation of Quality review meeting presentation to provide insight of quality elements in the shop floor.
Preparation of GAP assessments of practices vs procedures vs current Regulatory requirements.
Involving in the self-inspections and internal audits to ensure adherence to the laid down procedures.
Provoking Training from the user end at the shop floor to comply, Procedures vs Practices, Regulatory vs Current practices, and supporting perpetually.
Preparation of training modules on various topics viz., aseptic practices, environmental monitoring and execution of interventions, etc.
Providing SOP and GMP training for all New/ Existing employees.
Identifying the training needs of the personnel on the shop floor and ensuring the completion of training as per the scheduled intervals.
Maintaining the training records of the employees including the contract employees and consultants.
Bachelors degree isrequired in Pharmaceutical Science or Regulatory Affairs or Pharmaceutics.
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: SHIVA KUMAR KANGALA |
Company Type: Employer |
| Company: SHIVA KUMAR KANGALA |
|
|
|
| City: EAST BRUNSWICK |
|
| State: New Jersey |
|
| Zip: |
|
|
|
|
|
|
|