Opening for Lab QA at Zydus Topical Plant

1 week ago

Ahmedabad Gujarat, India Zydus Group Full time

Department
- OINTMENT FACILITY QA
- Job posted on
- Feb 09, 2025
- Employment type
- C-C7-Confirmed-HO Staff

**Department**:Quality Assurance

**Position title (if any)**:officer / Executive

**Reports to**:Section Incharge

**Qualification**: M.sc / B.pharm

**Experiences**: 2 to 5 years

**Description**:
Retention Sample management:
To ensure storage, maintenance and destruction of the control samples.

To issue control sample upon authorization by QA head with proper justification.

To perform periodic review of control sample.

QC Data Review /release:
To review analytical specifications, standard and general test procedures, test data sheet, and inspection plan for raw material, packing material, intermediate, drug substance, semi-finished, finished product, stability and microbiology.

Responsible daily oversight of document destruction process.

To review the data submitted by QC and cross check the calculations against the raw data / log book and to verify against the LIMS/SAP data recorded by the QC.

To ensure management of working/ reference/ impurity standard and column management.

To ensure contemporaneous documentation.

To check raw data /audit trail / software (as applicable) at a given frequency to ensure regulatory guidance compliance.

To review & verify electronic data/ audit trail before release/ reject the batch.

Responsible for QC release of the batch.

To review of stability protocols in coordination with stability group and review the stability report.

To review predictive stability analysis on data generated for stability study.

Review of analytical method transfer and method validation documents.

Review of calibration records of analytical Instruments.

To coordinate with CQA/ PTC department for implementation related to the official monographs/ General chapters/ corporate quality policy.

Reviews of documents i.e. risk assessment, change control, deviation and routine documents of testing area associated to the function.

To ensure retrieval of QC data and support for its presentation during audit.

Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy.

Controlled laboratory practice/ Laboratory Investigation:
To ensure controlled laboratory practice and GDP in area/instrument up keeping.

Responsible for quality oversight of personnel, process and practice to meet the compliance requirement.

To perform random checks in personal computers with respect to desktop policy and to ensure housekeeping of system and area.

To monitor the regular operations carried out in the testing areas and to ensure contemporaneous documentation.

To review the OOS/OOT/laboratory investigation and closure of the same.

To verify the training and qualification of analyst.

To evaluate and comment on change proposals initiated by QC laboratory.

To participate in investigation of the deviation/incidences, non-conformances, market complaints, OOS, OOT.

To evaluate and verify the CAPA proposed in the area of operation.

To conduct audit of service providers and to ensure review annual maintenance contract system.

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