Senior Executive - QA

Piramal Pharma Limited; Navi Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Piramal Pharma Limited is seeking a QA/QC professional to review and ensure data integrity of QC analytical data, calibrations, and batch records. The role includes supporting regulatory inspections and audits, with hands-on analytical work and strong SOP adherence.

The candidate will oversee QC lab activities, manage batch release, and contribute to CAPAs, deviations, and change controls in a fast-paced pharmaceutical environment.

Qualifications

• Review and evaluate QC analytical data for data integrity.
• Review specifications, STPs, procedures and SOPs.
• Assess QC instrument qualification and calibration status.
• Prepare and manage batch release processes.
• Hands-on analytical experience is required.
• Review batch records and audit trails for compliance.
• Prepare and review APR documents.
• Oversee QC lab activities to ensure SOP adherence.
• Initiate and review deviations, change controls, OOS/OOT, and CAPA.
• Conduct cleaning validation reviews per regulatory guidelines.
• Support during regulatory inspections and customer audits.

Responsibilities

• Review and evaluate QC analytical data for data integrity.
• Review specifications, STPs, procedures and SOPs.
• Assess QC instrument qualification and calibration status.
• Manage batch release processes.
• Hands-on analytical experience.
• Review batch records and audit trails.
• Prepare and review APR.
• Oversee QC lab activities to ensure SOP adherence.
• Initiate and review deviations, change controls, OOS/OOT, and CAPA.
• Conduct cleaning validation reviews per regulatory guidelines.
• Support during regulatory inspections and customer audits.

Skills

Data review

Data integrity

Audit trail

Analytical instruments

SOP compliance

Regulatory audits

Communication

Peptides knowledge

Job description

Role & responsibilities

• Review and evaluation of QC analytical data, including thorough electronic data and audit trail review to ensure data integrity.
• Review of analytical specifications, STPs/analytical procedures, protocols, and laboratory-related SOPs.
• Review of QC laboratory qualification/calibration status of analytical instruments.
• Batch Release Management.
• Hands on analytical experience.
• Review of batch manufacturing and packaging records, including audit trail verification.
• Preparation and Review of APR.
• Oversight and review of QC laboratory activities to ensure adherence to SOPs and quality standards.
• Initiation, investigation, and review of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
• Review and execution of cleaning validation activities in accordance with regulatory guidelines.
• Support during regulatory inspections and customer audits.

Preferred candidate profile

• Quick learner with excellent communication skills
• Punctual with proven track record of dedication & reliability
• A team player who is equally capable of working alone
• Fluent in both written and spoken English
• Knowledge /Experience in peptides