Executive I
Pharma
Executive-QualityAssurance,Pharma
Neural analysis suggests this role is
optimal for Entry candidates.
“Executive - Quality Assurance, Pharma at Executive I. Skills: Quality Assurance, Documentation, cGMP, GDP, Quality Systems, batch documentation, document control systems, APQR preparation, regulatory expectations, analytical skills, organizational skills, coordination skills, communication skills, cross-functional collaboration, data integrity. Line Clearance and shop floor compliance. Carry out in-process checks and calibration of IPQC instruments.”
What You'll Achieve.
Assuring quality of products
Industry & Context.
analytical skills; Gap analysis; Corrective actions/Preventive actions implementation
What They're Looking For.
Must Have
1–5 years of relevant experience in Pharma Quality Assurance / Documentation, knowledge of cGMP, GDP, and Quality Systems, Hands-on experience with batch documentation and document control systems, Good understanding of APQR preparation and regulatory expectations, analytical, organizational, and coordination skills, Effective communication and cross-functional collaboration abilities, Attention to detail and commitment to data integrity
What You'll Do.
Line Clearance and shop floor compliance
Carry out in-process checks and calibration of IPQC instruments.
Handle e tools i. e. SAP Hana
Assisting in Complaint Investigation system at site
Assisting in Qualification and validation system
change control system
Preparing & review the Annual Product Quality Review
Review of Batch Manufacturing & Packing Records
Coordination of cGMP Training activity.
Ensure adherence to company Quality Standards
Local FDA MHRA regulations
Ensure validated status of all equipment’s
manufacturing processes
and cleaning processes
Review of protocols for qualification and validation of facility/ equipment / product / process
Review of validation reports after execution of validation of facility /equipment / product / process
Preparation and Review of SOPs
Controlled distribution and archival of documents & record
Control of master documents
Ensuring SOP compliance
Review of Batch Manufacturing & Packing Records
Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
Ensuring the effectiveness review of the implemented CAPA
To prepare training modules and organize training in GMP
Execute the training program in coordination with all concerned departments
Review of maintenance and calibration program.
How You'll Work.
Team & Collaboration
cross-functional collaboration abilities; Coordination of cGMP Training activity.; Execute the training program in coordination with all concerned departments
Communication Scope
Effective communication; cross-functional collaboration abilities
Process & Methodology
compliance plan preparation, compliance plan execution
Full Job Description
Position Title: Executive I - Quality Assurance, Pharma **Qualifications & Experience** Educational Qualification * Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. **Experience** * 1–5 years of relevant experience in Pharma Quality Assurance / Documentation **Skills & Competencies** * Strong knowledge of cGMP, GDP, and Quality Systems * Hands-on experience with batch documentation and document control systems * Good understanding of APQR preparation and regulatory expectations * Strong analytical, organizational, and coordination skills * Effective communication and cross-functional collaboration abilities * Attention to detail and commitment to data integrity **Key Responsibilities** **** 1\. Quality Management/Continuous Improvement a. Line Clearance and shop floor compliance b. Carry out in-process checks and calibration of IPQC instruments. c. Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system. d. Assisting in Complaint Investigation system at site e. Assisting in Qualification and validation system, change control system, deviations f. Preparing & review the Annual Product Quality Review g. Review of Batch Manufacturing & Packing Records h. Coordination of cGMP Training activity. 2\. Compliance Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by i. Understanding the requirements ii. Performing the Gap analysis to find out the gaps in existing system iii. Preparing a compliance plan for closure of gaps iv. Execution of compliance plans v. Review of completion for compliance activity 3\. Validations & Qualifications: a. Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes b. Review of protocols for qualification and validation of facility/ equipment / product / process c. Review of validation reports after execution of validation of facility /equipment / product / process 4\. Documentation Control: a. Preparation and Review of SOPs
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