HYDERABAD · FULLTIME
Quality Assurance (AQA) Professional
Promea Therapeutics
Hyderabad · onsite · Posted 3d ago
Sourced from
Undisclosed12–17 yrsfulltimeHyderabad
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Section · 01
About this role
Key Responsibilities:
Key Skills & Competencies:
- Responsible for review of stability protocol & report.
- Responsible for Preparation of Annual Product Quality Review.
- Responsible for review of Master Packing Card & Master Formula Card.
- Responsible for preparation and review of Process validation Protocols and reports.
- Responsible for review of Batch Manufacturing and Batch Packing records
- Responsible for preparation of batch release certificate and ensuring batch release process performed as per the SOP.
- Responsible for issuance of Formats, Logbooks, Register, protocol, reports, BMRs and BPRs as per respective procedure.
- Responsible for review of QC documents such as Specifications and Standard Testing Procedure (RM, bulk, finished product, RST).
- Responsible for review of COAs (Raw Material, Packing Material & Finished Product).
- Sound knowledge of cGMP, GLP, and data integrity principles.
- Experience in review of analytical data generated through HPLC, GC, UV, IR, Dissolution, etc.
- Good understanding of analytical method validation and transfer.
- Proficient in documentation and good communication skills.
- Familiar with regulatory expectations (USFDA, MHRA, WHO, etc.).
Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
process validationCGMPAnalytical Method ValidationRaw MaterialHPLCBatch ManufacturingBatch ReleaseAnnual Product Quality ReviewQuality AssuranceCommunication SkillsManufacturingQCPacking Material
Section · Company
About Promea Therapeutics
Promea Therapeutics
Medical Equipment
501
employees
2017
9 years old
Hyderabad/Secunderabad, Telangana
India
About
Promea Therapeutics is an innovative medical device manufacturing company specializing in Life Science products, Diagnostics.
Industries
Medical EquipmentBiotechnologyPharma
Employee ratings
225 reviews
4.1/ 5
Culture
3.9
Career growth
3.7
Work-life
4.0
Employees rate it well for
Senior Management31Learning28Work Culture26Work Environment24Team Members14
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