Quality Control Executive Api

3 days ago

Ahmedabad Gujarat, India Nexus pharmachem Pvt Ltd Full time

Job Responsibility

Must have Knowledge of Analytical Method Validation

Must have Knowledge of Gas Chromatography

Must have Knowledge of HPLC

Preparing specifications for all raw materials, finished products, intermediates, solvents, and reagents used in analyses.
- Inspecting, sampling and testing of all starting materials including packaging materials.
- and finished products as per procedures defined in the Standard Operating Procedures.
- Performing stability testing to assess product stability.
- Monitoring environmental conditions are met as per current Good Laboratory Practices (CGLP).

Validation of analytical methods used in the testing.
- Reviewing the batch manufacturing and packing records and assessing the test reports to ensure.
- Products are of the desired quality and have been properly packed and labelled.
- To prepare SOPs, reviews for biannual review. Prepare Training outlines.
- To prepare testing specifications.
- To prepare, review and update working standards.
- To maintain calibration records of instruments.
- Prepares analytical reports and certificates of analysis.
- To prepare stability protocols and evaluate stability data.
- To validates stability indicating methods.
- Preparation of Certificate of Analysis.

To maintain respective working area, documents, and records in auditable manner.

Responsible for Labeling, sampling, testing and release of all raw Materials, Packaging Material and Consumable Material.
- Ability to carryout wet-lab analysis
- Responsible for maintenance of volumetric, Reagent, indicator solution for testing of raw Materials, packaging Material and consumable Material.
- Responsible for Water Testing.
- Preparation and review documents related Raw Material/ Packaging Material/Consumable Material. (MOA/DRS/SPC/SOP)
- Involved in Calibration and Equipment Qualification as and when required.
- Review of Log Book, Calibration Records and Volumetric/Test Solutions Records.
- Responsible for outsourcing of sample testing purpose.
- Involved in IPQC, DS & DP testing and their related documentation as and when required.
- Involved in Inventory management for stock chemical, Kits/consumables of whole QC and its reconciliation record maintenance.
- Involved in Final and intermediate Release of Batch as when required.
- Involved in QMS documentation activities like Incident, Deviation, Change control, CAPA etc...
- Preparation & standardization of solutions and reagents

Analytical method validation, OOS and OOT.

Instrument Knowledge Required

HPLC

GC

UV Spectrophotometer

Karl Fischer

Polari meter

Role: QCExecutive

Industry Type: Pharmaceutical & Life Sciences

Department: Quality Control

Employment Type: Full Time, Permanent

Role Category: Analysis and Document

**Education**

UG: B.Sc / B.Pharm in Chemistry

PG: M.Sc/M.Pharm in Chemistry

Resume (CV) Required

**Job Types**: Full-time, Permanent

**Benefits**:

- Leave encashment

Ability to commute/relocate:

- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Quality control: 1 year (preferred)

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