- Location
- Ankleshwar, India
- Type
- Full-time
- Department
- IT
- Source
- Workday
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
b. Controlled distribution and archival of documents & record
c. Control of master documents
5. Assuring quality of products by :
a. Ensuring SOP compliance
b. Review of Batch Manufacturing & Packing Records
c. Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
d. Ensuring the effectiveness review of the implemented CAPA
6. cGMP Training:
a. To prepare training modules and organize training in GMP
b. Execute the training program in coordination with all concerned departments
7. Other:
a. Review of maintenance and calibration program.
