1. Officer / Executive – Regulatory Affairs
S Kant Healthcare Ltd. is hiring for its Vapi, Gujarat location. The company has announced an opening for Officer / Executive – Regulatory Affairs for candidates with a pharmacy background and relevant experience in regulatory documentation and submissions.
Job Overview
| Company | S Kant Healthcare Ltd. |
| Position | Officer / Executive – Regulatory Affairs |
| Location | Vapi, Gujarat |
| Qualification | B.Pharm / M.Pharm |
| Experience | 3 – 5 Years |
| Application Mode | Email Application |
Responsibilities
- Co-ordinate, collect and review dossier submission documents, including CMC data, from various departments like QA and QC.
- Address observations related to OOT/OOS, if any, to Head QA and Head QC.
- Review CCF and send monthly updates to the RA team and follow up for impacted documents from QC/QA.
- Prepare extrapolation of stability data as per ICH Q1E – Evaluation of Stability Data guideline.
- Prepare Certificate of Pharmaceutical Products (COPP).
- Prepare and submit documents along with samples for tender submission.
- Prepare and timely submit pharmaceutical product questionnaires and technical questionnaires for various international agencies.
- Assist in responding to queries raised by the Ministry of Health, international agencies and various customers.
- Ensure order processing for all international agency purchase orders in accordance with their requirements.
- Manage regulatory samples.
- Ensure housekeeping and laboratory discipline.
- Review, compile and submit CMC documents to CMO/CMDO for EU/MHRA submissions.
Qualifications
- B.Pharm / M.Pharm
Experience Required
- 3 – 5 years of relevant experience
How to Apply
Interested candidates can share their CV by email.
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2. Officer – IPQA
S Kant Healthcare Ltd. is also inviting applications for Officer – IPQA at Vapi, Gujarat. This role is suitable for B.Pharm or M.Pharm candidates with 0 – 3 years of experience in IPQA-related activities and quality system documentation.
Job Overview
| Company | S Kant Healthcare Ltd. |
| Position | Officer – IPQA |
| Location | Vapi, Gujarat |
| Qualification | B.Pharm / M.Pharm |
| Experience | 0 – 3 Years |
| Application Mode | Email Application |
Responsibilities
- Review and ensure compliance of IPQA related activities as per SOPs and cGMP guidelines.
- Review documentation related to in-process, finished products and investigations, including deviation, OOS, change control and CAPA.
- Coordinate with Production, QA, QC and other departments for effective implementation of IPQA activities.
- Ensure data integrity, documentation and regulatory compliance.
- Support in preparation of various reports and audits.
- Contribute towards continuous improvement in quality systems.
Qualifications
- B.Pharm / M.Pharm
Experience Required
- 0 – 3 years of relevant experience
How to Apply
Interested candidates can share their CV by email.
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