Urgently Opening for RA Post and QA Post
- Designation : Executive/Sr.Executive- RA
- Experience : 3 to 10 years
- Salary Negotiable
- Job Location Mahape (Near Ghansoli)
- Salary: 2.5-6 Lacs P.A.
Walk-in interview details
- Time and Venue
- 5th October – 13th October , 9.30 AM – 5.00 PM
- Ghansoli, Mahape
- Contact – Prajakta Jadhav ( 9594111529 )
Desired candidate profile Skills & Strength :
- Must be excellent in written and verbal communication in English.
- Good organized work.
- Ability of multi-tasking.
- Team building ability & to work as a supportive team member.
- Knowledge of Ms-Word & Ms-Excel is must.
Role and Responsibility :
- To prepare dossiers for drug product registration, renewal and variation applications in ROW countries as per National, ACTD, CTD format, as per the requirement for registration purposes.
- To co-ordinate for technical documents and samples, required for regulatory submission, with various departments.
- Detailed review of the technical documents, to ensure it meets the regulatory requirements.
- Preparing query responses received from various registration agent and regulatory authorities, pertaining to regulatory submissions.
- To arrange BCCI attestation and country specific embassy legalization of various legal documents.
- To prepare courier documents for sending registration dossiers and samples.
- To maintain up to date status of ongoing dossiers/queries/other related works, for reporting to Senior/HOD.
- Package Insert Preparation.
- Medication Guide Preparation.
- To check Art Works considering the product approval, pharmacopoeia and country specific standards.
- Assigning/checking Carton Bar Code.
- Assigning/checking Shipper Bar Code.
- Maintaining Packing Material Status.
- PVSS Checking for FDA submission.
- Draft Label Checking.
Interested Candidates Can mail me CV on – prajaktajadhav@sgpharma.com
Connect on -9594111529
Urgently Hiring
Designation : QA
Executive/Sr.Executive
Experience : 3 to 8 years
Salary Negotiable Qualification- B-Pharma or M-Pharma/BSc.-Chemistry/MSc.Chemistry Job Location Mahape (Near Ghansoli)
Skills & Strength :
- Must be good in written and verbal communication in English. • Good organized work & time management. • Team building ability & to work as a supportive team member. • Observation & Analytical Skills • Knowledge of Ms-Word & Ms-Excel is must. • Good hands on experience on Lab Instruments.
Role and Responsibility :
- Location Audit (Destruction, GMP Compliance, Market complaint)
- PTL Audit
- Vendor Audit
- Review of Batch Release documents and Batch Release Certificates.
- Preparation, approval and implementation of SOPs.
- Artwork / Imposition, Shade Cards checking and approval.
- Review and approval for packing material received at our stores & from location.
JOB DESCRIPTION
- Preparation, controlling, issuance & revision of BMR & BPR
- Initiation, review, monitoring, tracking and closure of change control.
- Review of Batch Documents (i.e. BMR, BPR, Analytical reports)
- Assist in Handling Market Complaint, Internal Quality Audit, CAPA management
Preparation and authorisation of Production information file.
- Maintain records of BMR received from location, review of the same and follow up with Production and Location in case of any deviation found. Maintain scan copy of relevant BMR.
- Review of dossier and authorisation.
- Coordination and communication with location.
- Review of AMV.
- Induction and orientation to new QA staff.
- Control & follow up of starting material upto FP release from location.
- Review and issue of Batch Coding.
- Interdepartmental coordination/discussion/meeting if needed and reporting to management.
- Ensuring the requirements completed within scheduled time.
- Preparation, issuance, controlling & revision of SOPs
- Preparation APQR Reports
Interested Candidates Can mail me CV on – prajaktajadhav@sgpharma.com
Connect on -9594111529
