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SAVA HEALTHCARE LIMITED
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QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)

QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)

SAVA HEALTHCARE LIMITED

5 years

0 Lacs

Etawah Uttar Pradesh India

Posted:1 month ago| Platform:

Apply

Skills Required

qc stability microbiology manufacturing reporting testing analysis support monitoring documentation compliance reports lims erp audits calibration maintenance coordination resolve data integrity communication collaboration certifications training

Work Mode

On-site

Job Type

Full Time

Job Description

Job Title:

QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)

Location:

Indore – Regulated Pharma Manufacturing Plant

Department:

Quality Control

Reporting To:

QC Manager / Head – Quality Control

Job Type:

Full-Time | Executive Level

Job Purpose

To perform quality control testing and analysis of raw materials, finished products, stability samples, and microbiological parameters as per current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), pharmacopeial standards, and regulatory requirements to ensure product quality and compliance.

Key Responsibilities

Testing and Analysis

Perform chemical and instrumental testing of

Raw Materials (RM)

and

Finished Goods (FG)

as per pharmacopeial and in-house specifications.Conduct

Stability Studies

in line with ICH guidelines and maintain records of stability trends.Execute

Analytical Method Validations (AMV)

and support

Process Validation (PV)

testing.Carry out

Microbiological analysis

of samples, including environmental monitoring, water testing, and microbial limit tests.

Documentation and Compliance

Maintain accurate, complete, and timely documentation (analytical reports, logbooks, LIMS/ERP entries).Ensure compliance with

cGMP, GLP, and regulatory standards (USFDA, EU-GMP, WHO, etc.)

.Participate in

internal audits, external regulatory inspections

, and implement CAPAs.Prepare and review standard operating procedures (SOPs), specifications, and testing protocols.

Equipment Operation & Calibration

Operate and calibrate instruments like HPLC, GC, UV, IR, Dissolution Apparatus, FTIR, etc.
Ensure timely preventive maintenance and validation of QC instruments.

Cross-functional Coordination

Coordinate with Production, QA, Regulatory Affairs, and other relevant departments to resolve testing issues and support product release timelines.Participate in investigations of OOS/OOT results, deviations, and change controls.

Key Skills & Competencies

Sound knowledge of cGMP/GLP and ICH guidelines.Hands-on experience with analytical instruments and microbiology techniques.Strong documentation and data integrity practices.Good communication and team collaboration skills.Eye for detail and high level of integrity.

Educational Qualifications

B.Pharm / M.Pharm / M.Sc. (Chemistry / Microbiology / Pharmaceutical Sciences)

Experience

2–5 years of relevant experience in a regulated pharmaceutical manufacturing environment.

Preferred Certifications

Training in

Data Integrity, cGMP, QMS, or Instrument Handling

is an advantage.

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QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Job Title:

Location:

Department:

Reporting To:

Job Type:

Job Purpose

Key Responsibilities

Raw Materials (RM)

Finished Goods (FG)

Stability Studies

Analytical Method Validations (AMV)

Process Validation (PV)

Microbiological analysis

cGMP, GLP, and regulatory standards (USFDA, EU-GMP, WHO, etc.)

internal audits, external regulatory inspections

Key Skills & Competencies

Educational Qualifications

Experience

Preferred Certifications

Data Integrity, cGMP, QMS, or Instrument Handling

More Jobs at SAVA HEALTHCARE LIMITED