Officer

Lupin Ltd; Goa; On-site; INR 480,000 - 640,000; Full time

Job summary

Lupin Ltd in Goa seeks a QA/QC professional for in-process sampling and testing, and for ensuring compliance with SOPs and EHS requirements.

The role involves handling finished product sampling, hold time studies, and document review of BRRs/ESPs in PAS-X, along with calibration and qualification activities. Graduation and 1–3 years of pharma QA/QC exposure are expected.

Qualifications

• 1-3 years of experience in QA/QC in pharma manufacturing.
• Experience with sampling and testing of finished products.
• Knowledge of GMP/GLP and related SOPs.

Responsibilities

• In-process sampling and testing.
• Finished product sampling (bulk finish and packed samples).
• Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
• Quality Assurance to note deviations from systems and SOPs and record observations.
• Maintenance of instruments in IPQC and routine calibration.
• Review log books and environmental monitoring files.
• Review records such as equipment usage, cleaning, area usage, balance calibration, etc.
• Line clearances for production activities in the department.
• Release/approval of BRRs and ESPs in PAS-X System.
• Review and approval of batch manufacturing and batch packing records.
• Participation in equipment qualifications and cleaning validation.

Skills

In-process sampling

Finished product sampling

Hold time study

Quality Assurance

Instrument calibration

Environmental monitoring

PAS-X System

Batch records

Equipment qualification

Cleaning validation

EHS compliance

Education

Graduation

Post Graduation in Pharmacy

Job description

• Finished product sampling (Bulk finish and Packed samples).
• Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
• Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.
• Maintenance of instruments in the IPQC & routine calibration.
• Review log books and environmental monitoring files.
• Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.
• Line clearances for different activities in the Production Department.
• Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.
• Execution, review and approval of batch manufacturing records and batch packing records.
• Participate in equipment qualifications as per the requirements.
• Execution of cleaning validation & equipment qualification.
• Execution of Customer requirements (Samples and Documents).
• Review, preparation and revision of documents as per requirement.
• To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements & Applicable Legal Compliances.

Job Description

• In-process sampling and testing.
• Finished product sampling (Bulk finish and Packed samples).
• Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
• Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.
• Maintenance of instruments in the IPQC & routine calibration.
• Review log books and environmental monitoring files.
• Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.
• Line clearances for different activities in the Production Department.
• Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.
• Execution, review and approval of batch manufacturing records and batch packing records.
• Participate in equipment qualifications as per the requirements.
• Execution of cleaning validation & equipment qualification.
• Execution of Customer requirements (Samples and Documents).
• Review, preparation and revision of documents as per requirement.
• To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements & Applicable Legal Compliances.

Work Experience

1 to 3 Years

Education

Graduation

Post Graduation in Pharmacy

Competencies

• In-process sampling and testing.
• Finished product sampling (Bulk finish and Packed samples).
• Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
• Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.
• Maintenance of instruments in the IPQC & routine calibration.
• Review log books and environmental monitoring files.
• Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.
• Line clearances for different activities in the Production Department.
• Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.
• Execution, review and approval of batch manufacturing records and batch packing records.
• Participate in equipment qualifications as per the requirements.
• Execution of cleaning validation & equipment qualification.
• Execution of Customer requirements (Samples and Documents).
• Review, preparation and revision of documents as per requirement.
• To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements & Applicable Legal Compliances.

Job Description

• In-process sampling and testing.
• Finished product sampling (Bulk finish and Packed samples).
• Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
• Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.
• Maintenance of instruments in the IPQC & routine calibration.
• Review log books and environmental monitoring files.
• Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.
• Line clearances for different activities in the Production Department.
• Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.
• Execution, review and approval of batch manufacturing records and batch packing records.
• Participate in equipment qualifications as per the requirements.
• Execution of cleaning validation & equipment qualification.
• Execution of Customer requirements (Samples and Documents).
• Review, preparation and revision of documents as per requirement.
• To comply all EHS Rules, Procedures, Guidelines, Policy, Practices, Requirements & Applicable Legal Compliances.

Work Experience

1 to 3 Years

Education

Graduation

Post Graduation in Pharmacy

Competencies