Role & responsibilities

Position: APQR Consultant
Locations: Hyderabad / Vapi
Experience Required: 1+ Years

Male Candidates Preferred

Job Summary

We are seeking a detail-oriented APQR Consultant with at least 1 year of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in the Review and Preparation of Annual Product Quality Reviews (APQRs), along with a strong understanding of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). The role involves analyzing manufacturing and quality data, ensuring regulatory compliance, and supporting continuous improvement initiatives.

Key Responsibilities

- Review and prepare Annual Product Quality Review (APQR) reports in compliance with cGMP and regulatory requirements.
- Collect, analyze, and interpret manufacturing, quality control, stability, deviation, change control, and complaint data for APQR preparation.
- Evaluate process performance trends and identify opportunities for continuous improvement.
- Perform assessment and trending of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs).
- Review deviations, OOS/OOT results, change controls, CAPAs, and product complaints as part of APQR activities.
- Collaborate with Quality Assurance, Manufacturing, Quality Control,



and Regulatory Affairs teams to ensure completeness and accuracy of APQR documentation.
- Support process validation and continued process verification activities.
- Ensure compliance with regulatory guidelines, company SOPs, and data integrity requirements.
- Participate in audits and inspections by providing APQR-related documentation and responses.
- Preferred candidate profile

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- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related discipline.
- 1+ years of experience in APQR review and preparation within the pharmaceutical industry.
- Hands-on experience in CPP and CQA evaluation, trending, and analysis.
- Good understanding of cGMP, ICH guidelines, FDA, EU GMP, and other applicable regulatory requirements.
- Robust analytical, documentation, and reporting skills.
- Proficiency in MS Excel and data analysis tools.

Preferred Skills

- Knowledge of process validation and continued process verification.
- Experience in handling deviations, CAPAs, change controls, and product complaints.
- Strong communication and cross-functional collaboration skills.
- Ability to work independently and manage multiple APQR projects within timelines.

📌 APQR Consultant (Hyderabad)
🏢 Proventech
📍 Hyderabad