Acme Generics LLP Released Job Openings On 13-09-2021.A Leading Pharma Group with Global Presence and approvals from EU-GMP, MHRA-UK, ANVISA Brazil, PICS Ukraine, WHO Geneva, INVIMA Colombia, USFDA*
Acme Generics LLP Recruiting B.Pharma,M.Pharma Candidates with 20 – 30 years of Experience for Quality Head – Solid Oral Position.Complete Details for the Quality Head – Solid Oral as follows.
Important Details :
- Location :Baddi
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 13/09/2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Step
Job Description/Skills Required
Note: Please apply who are working on parallel position in Pharma OSD Formulations Only.
- Responsible for provide the solutions to improvement of Quality Management System, Validations, Regulatory compliance, Process Remediation, Gap Assessment, Risk Analysis and Risk Management and compliance to Regulatory Audit observations.
- Review and Approve of Investigations, Risk Assessment of Manufacturing and Quality Deviations including Out of Specification (OOS) results, Out of Trend (OOT), Review and Approval of Product Quality complaints, Product Quality Recall, Annual Product Quality Review, Validation documents, Vendor Management Documents, Internal Quality Audits (Self-Inspections) and Proposed Corrective and Preventive Action (CAPA), Cleaning validation documents etc.
- Effective implementation of change control system to evaluate all changes that may affect the manufacturing controls and documents.
- Handling of Customer Complaints, Product Recalls and Returned Goods & Field alerts.
- Working experience for review and audit submission documents along with supporting data related to R&D, Production, Quality control and Regulatory Affairs.
- Co-ordination for Management Reviews and Technology Transfer.
- Ensuring all critical (stability indicating) methods using for release of commercial products are validated / verified.
- Ensuring that all manufacturing process are validated for the products meant for commercial distribution.
- Ensuring that all the documents / records for products manufactured and tested for commercial distribution is prepared, reviewed and approved and all deviations are approved before commercial distribution.
- Experience in Performing and Monitoring GMP activities.
- Responsible for Audit response & Compliance.
- Responsible for Review & Approve documents generated within the laboratory through analysis related to In process, Finished Product, Stability, GLP, Raw Material, etc.
- Responsible for Vendor Audits, CMO & Compliance