Drug Regulatory Affairs Executive

2 weeks ago

Lucknow, India TRS Consulting Solution Full time

Mandate Industry Experience:

- Pharma industry like Medical Manufacturing (Tabs/Caps/Inj Manufacturing) etc

Job Description & Skill Requirement
- Well versed in management of Dossier Preparation (documentation)and quality issued thru various quality management
- Exp professional in supplier quality management activities in the medical, pharma industry.
- Excellent team Coordination skills
- Experience in handling complex quality problems,Troubleshoot quality/compliance issues using experience and creativity to provide solutions to a wide range of root causes towards dossier queries from clients from different countries under their regulatory guidelines.
- Full awareness of end to end supplier quality Management include supplier selection, qualification,performance management, ASL Management, change control management, Non-conformance management, CAPA management, COPP and Product Permissions requirements,paper based audit management, quality agreement management
- Review product records to confirm that Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) requirements are met. And vetting the document with 100% proofing.
- Good analytical skills
- Understanding of regulatory requirements for various Consumer/pharmaceutical products.
- Able to handle supplier communication for providing end resolution simultaneously.

**Should be well verse in making all type of dossiers**

MHJ PHARMACONCEPTS PRIVATE LIMITED

**Salary**: ₹175,972.69 - ₹895,036.80 per year

Schedule:

- Day shift

Ability to commute/relocate:

- Lucknow, Uttar Pradesh: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 9452020159

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