Walk-in || QA Officer/Executive
The QA Executive is responsible for ensuring that all manufacturing, packaging, storage, and documentation activities comply with Good Manufacturing Practices (GMP), regulatory requirements, company SOPs, and quality standards. The role supports quality systems, in-process quality assurance, validation activities, audits, and continuous improvement initiatives.
Time and Venue
14th July , 9.30 AM – 5.30 PM
SNA Healthcare Private Limited, Plot No. T-8 and T-9, MIDC Road, Tarapur, Boisar West, 401506.
Contact – Babita Tiwari ( 7666036008 )
Roles & Responsibilities
Quality Management System (QMS)
- Ensure compliance with GMP, GDP, and company Quality Management System requirements.
- Prepare, review, and control SOPs, specifications, formats, protocols, and quality documents.
- Maintain document control and revision history.
- Participate in quality risk management and continuous improvement initiatives.
In-Process Quality Assurance (IPQA)
- Perform line clearance before manufacturing and packaging activities.
- Monitor manufacturing operations to ensure compliance with approved Batch Manufacturing Records (BMRs), SOPs, and GMP requirements.
- Verify equipment cleanliness, status labels, and environmental conditions.
- Ensure adherence to in-process controls and sampling procedures.
Batch Documentation
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), logbooks, and analytical records for completeness and compliance.
- Verify documentation accuracy and ensure Good Documentation Practices (GDP) are followed.
- Coordinate timely closure of batch documentation.
Deviations, CAPA & Change Control
- Investigate deviations, non-conformances, and out-of-limit observations.
- Prepare and implement Corrective and Preventive Actions (CAPA).
- Participate in change control assessments and implementation.
- Support root cause analysis using quality tools.
Validation & Qualification
- Assist in process validation, cleaning validation, equipment qualification, and utility qualification activities.
- Review validation protocols and reports.
- Ensure validation documentation complies with regulatory requirements.
Audits & Regulatory Compliance
- Support internal audits, self-inspections, customer audits, and regulatory inspections.
- Ensure audit readiness of manufacturing and documentation.
- Prepare compliance reports and close audit observations within timelines.
Product Release & Quality Review
- Verify that all quality requirements are met before batch disposition.
- Coordinate with QC, Production, Warehouse, and Regulatory departments for timely batch release.
- Review product quality trends and recommend improvements.
Training
- Conduct GMP, GDP, SOP, and quality system training for employees.
- Maintain training records and evaluate training effectiveness.
Coordination
- Work closely with Production, QC, Warehouse, Engineering, and Regulatory Affairs to ensure quality compliance.
- Support investigations related to customer complaints, market complaints, and product recalls when required.
Safety & Compliance
- Follow EHS guidelines and company safety procedures.
- Ensure compliance with data integrity, documentation, and regulatory requirements.
- Promote a culture of quality and continuous improvement.
Required Skills
- Strong knowledge of GMP, GDP, GLP, ICH guidelines, and regulatory requirements.
- Experience in API manufacturing processes and quality systems.
- Knowledge of BMR/BPR review, deviations, CAPA, change control, and validation.
- Familiarity with internal and external audits.
- Good analytical, documentation, and problem-solving skills.
- Proficiency in MS Office and ERP systems.
- Excellent communication and interpersonal skills.
Key Performance Indicators (KPIs)
- GMP compliance and audit readiness.
- Timely review and closure of batch documentation.
- On-time closure of deviations, CAPA, and change controls.
- Successful completion of validation activities.
- Reduction in quality incidents and documentation errors.
- Timely completion of internal audits and compliance actions.
- Training completion and effectiveness.
- Customer and regulatory audit performance.
Preferred Candidate Profile
- 3 to 5 years of experience in Quality Assurance within an API or Pharmaceutical Manufacturing Company.
- Strong understanding of WHO-GMP, ICH guidelines, and regulatory expectations.
- Experience handling quality systems, documentation, audits, and validation activities.
- Ability to work independently and collaboratively in a cross-functional environment.