Deputy Manager – QC

Qvents.In

Kolkata Metropolitan Area

On-site

INR 1,400,000 - 2,000,000

Full time

12 days ago

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Job summary

Piramal Pharma Solutions (PPS) in Digwal, Telangana, India seeks a Deputy Manager for QC to oversee Labware LIMS management, document controls, and laboratory workflows. The role ensures FDA/cGMP compliance, manages COA generation, stability protocols, validation activities, and timely review of data and audits.

The candidate will supervise QC documentation, calibration records, and vendor coordination while ensuring inventory of standards and reagents is maintained for analysis.

Qualifications

QC Experience in Regulated Pharma
Experience handling LIMS, cGMP documents in QC, Incident Investigation

Responsibilities

Responsible for Labware LIMS Masters and Routine execution and trouble shooting, Interface issues resolution
To allocate work of chemical and Instrumentation area and ensure timely completion of work. Ensure allocated work is in line with Analyst Qualification reports.
Analyticla data Review, Investigation and Change controls and QMS activities.1. Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement.
Preparation and checked by of the COA’s for RM,PM,FP,API IMT and working standard etc..
Prepare Stability Schedule, Stability protocol and Report, Validation/ Qualification, Trending reports.
Review Qualification, Validation, Calibration data, Procedures, Protocol, Audit Trail on timely manner.
Review QC Logs, Incidences, Reports and ensure document archival after released of samples.
Ensure Control sample inspection and Leftover sample disposal after analysis.
Ensure Instrument calibration and AMC done as per the schedule.
Prepared and Revised SOPs, Specification and Procedure in line with Regulatory requirement.
Review of packing materials, raw materials, stability samples, in process and finished products data.
Overall responsible for Internal & External vendor follow ups and completions within the timelines.
Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required.

Skills

LIMS Management

QC Documents Review

Laboratory Work Allocation

QMS Activities

Data Review & Investigation

Calibration & Validation Review

SOPs & Documentation

Vendor Follow-ups

Inventory & Stock Mgmt

Regulatory Compliance

Education

Graduates/ Post Graduates Science/ Pharmacy

Tools

LIMS

Job description

Designation : Deputy Manager

Reporting To : ,

Function : QC

Functional Area : Quality Control

Job Role Summary : Labware LIMS Management, QC Documents Review, Laboratory Work Allocation, QMS activites

Job Profile

Responsible for Labware LIMS Masters and Routine execution and trouble shooting, Interface issues resolution
To allocate work of chemical and Instrumentation area and ensure timely completion of work. Ensure allocated work is in line with Analyst Qualification reports.
Analyticla data Review, Investigation and Change controls and QMS activities.1. Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement.
Preparation and checked by of the COA’s for RM,PM,FP,API IMT and working standard etc..
Prepare Stability Schedule, Stability protocol and Report, Validation/ Qualification, Trending reports.
Review Qualification, Validation, Calibration data, Procedures, Protocol, Audit Trail on timely manner.
Review QC Logs, Incidences, Reports and ensure document archival after released of samples.
Ensure Control sample inspection and Leftover sample disposal after analysis.
Ensure Instrument calibration and AMC done as per the schedule.
Prepared and Revised SOPs, Specification and Procedure in line with Regulatory requirement.
Review of packing materials, raw materials, stability samples, in process and finished products data.
Overall responsible for Internal & External vendor follow ups and completions within the timelines.
Responsible to procure and maintain the minimum stock for working standards, reference standards, impurity standards, chemicals, reagents, glass wares and solvents required for analysis and ordering as and when required.