Company: Zeno Health
Post: QA/QC Executive
Experience: Relevant
Qualification: M.Pharm/B.Pharm
Location: Bhandup, Mumbai
Job Description:
- An expert in Handling Oral Solid Dosage Forms, Oral Liquid Dosage forms & Injectables / Parenteral from a QA/QC Manufacturing Standpoint
- Manage / Implement the QA/QC systems and process through SOPs at Corporate Office in alignment with the Manufacturing Facilities
- Communicate with the Manufacturer on Documentation / Product Tech Pack relating to New product Approvals / Compliance
- Handle contract manufacturing Facilities by carrying out their periodic Facility and Product Audits along with timely revert to the Manufacturing Vendors on Audit findings and its closures
- Identify Non-Conformances and work towards closure with RCA and CAPA
- Process Internal QA/QC reviews on a monthly basis
- Close coordination with the Internal Teams on Quality Oriented communications
- Coordination with Contract testing labs
Desired Experience, Skills and Expertise:
- Hands-on experience with Excel
- Knowledge and prior experience in handling SAP software for QA/QC
- Vendor Management (Product and Facility Audit)
- B. Pharma/ M. Pharma and above
- Minimum 3 years of Experience in Auditing Manufacturing Facilities & 2 years of Corporate Quality Functions
- Good written and verbal communication skills
- Self-driven and motivated
- Experience in working with Third Party Laboratories for product Testing
- Experience in Auditing / faced WHO, EU GMP and USFDA certified Facilities
- Awareness of Pharmacopoeia, WHO GMP, Schedule M & ICH Guideline
- Awareness of D&C Act 1954 from Artwork Management and Regulatory Standpoint
- Willing to work in a fast pace, challenging environment in a Start-up
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