Executive - Quality Assurance, Pharma

Zentiva; Ankleshwar; On-site; INR 400,000 - 600,000; Full time

Benefits offered by this job

Health insurance

Training programs

Career development opportunities

Job summary

Zentiva in Ankleshwar, Gujarat, is seeking an Executive I - Quality Assurance to ensure compliance with quality standards and regulatory expectations in the pharmaceutical industry. The role involves managing quality documentation, conducting training, and performing gap analysis.

The ideal candidate holds a Bachelor’s or Master’s degree in Pharmacy or a related field with 1–5 years of relevant experience. Strong knowledge of cGMP and effective communication skills are essential. An attractive salary and benefits package will be offered.

Qualifications

• 1–5 years of relevant experience in Pharma Quality Assurance / Documentation.
• Strong analytical, organizational, and coordination skills.
• Effective communication and cross‑functional collaboration abilities.

Responsibilities

• Ensure compliance with company Quality Standards and regulations.
• Assist in preparation and review of the Annual Product Quality Review.
• Coordinate cGMP Training activities.

Skills

Knowledge of cGMP

Knowledge of GDP

Quality Systems

Analytical skills

Organizational skills

Effective communication

Attention to detail

Education

Bachelor's or Master's degree in Pharmacy or related discipline

Tools

SAP Hana

LIMS

eDMS

TrackWise system

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

• Quality Management/Continuous Improvement.
• Line Clearance and shop floor compliance.
• Carry out in‑process checks and calibration of IPQC instruments.
• Handle e‑tools such as SAP Hana, LIMS, eDMS, and TrackWise system.
• Assist in Complaint Investigation system at site.
• Assist in Qualification and validation system, change control system, deviations.
• Prepare and review the Annual Product Quality Review.
• Review Batch Manufacturing and Packing Records.
• Coordinate cGMP Training activity.
• Compliance with company Quality Standards and local FDA/MHRA regulations:

Compliance, Gap Analysis and Plan Execution

1. Understand the requirements.
2. Perform the Gap analysis to identify gaps in the existing system.
3. Prepare a compliance plan for closure of gaps.
4. Execute compliance plans.
5. Review completion of compliance activities.

Validations & Qualifications

• Ensure validated status of all equipment, manufacturing processes, and cleaning processes.
• Review protocols for qualification and validation of facilities, equipment, products, and processes.
• Review validation reports after execution of validation of facility, equipment, product, and process.

Documentation Control

• Preparation and review of SOPs.
• Controlled distribution and archival of documents and records.
• Control of master documents.

Quality Assurance Activities

• Ensure SOP compliance.
• Review Batch Manufacturing and Packing Records.
• Ensure implementation of Corrective Actions and Preventive Actions proposed in deviations and customer complaints.
• Ensure effectiveness review of the implemented CAPA.

cGMP Training

• Prepare training modules and organize training in GMP.
• Execute the training program in coordination with all concerned departments.

Other

• Review maintenance and calibration program.