Assistant Manager - Pharmaceutical Quality Assurance

Vaayath Consulting Services; Chandigarh, Panchkula, Zirakpur; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Vaayath Consulting Services in India provides expert regulatory consulting to pharmaceutical manufacturers, helping ensure compliance with national and international guidelines. You will interpret requirements, assist with dossiers, and support regulatory inspections.

The ideal candidate has a pharmacy or related degree, strong GMP/QMS experience, and proven ability to review data, write technical documents, and travel for client audits across India.

Qualifications

• Educational background in Pharmacy or related discipline.
• Strong experience in Pharmaceutical Quality Assurance, Quality Control, or Regulatory Affairs.
• GMP audits, compliance assessments, and regulatory documentation review.

Responsibilities

• Provide expert consulting to pharmaceutical manufacturers on regulatory compliance under national and international guidelines.
• Interpret and apply regulatory requirements including Drugs & Cosmetics Act, GMP guidelines, pharmacopeial standards, and other regulatory frameworks.
• Assist clients in preparation, review, and submission of regulatory dossiers and responses to regulatory authority queries.
• Conduct desk reviews and on-site evaluations of Quality Management Systems.
• Review documentation such as BMRs, BPRs, Specifications, SOPs, Validation protocols, and Quality Manuals.
• Identify compliance gaps and recommend corrective measures aligned with regulatory expectations.
• Conduct GMP audits, vendor audits, and due-diligence audits for pharmaceutical manufacturers and related industries.

Skills

Regulatory affairs

GMP audits

QMS

Documentation

Data integrity

Technical writing

Client communication

Education

Master's in Pharmacy

Bachelor's in Pharmacy

Tools

MS Office

Job description

Role & Responsibilities

• Provide expert consulting support to pharmaceutical manufacturers on regulatory compliance under applicable national and international guidelines.
• Interpret and apply regulatory requirements including applicable provisions of the Drugs & Cosmetics Act & Rules, GMP guidelines, pharmacopeial standards, and other regulatory frameworks.
• Assist clients in preparation, review, and submission of regulatory dossiers, technical documents, and responses to regulatory authority queries.
• Conduct comprehensive desk reviews and on-site evaluations of Quality Management Systems.
• Review and assess documentation such as Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), Specifications, Standard Operating Procedures (SOPs), Validation protocols, and Quality Manuals.
• Identify compliance gaps and recommend practical corrective measures aligned with regulatory expectations.
• Conduct GMP audits, vendor audits, and due-diligence audits for pharmaceutical manufacturers, API producers, and related industries.
• Prepare detailed audit reports highlighting observations, risk assessments, and recommended corrective actions.
• Support organizations in preparing for regulatory inspections by national and international authorities.
• Evaluate quality systems including deviation management, change control, OOS/OOT investigations, and CAPA effectiveness.
• Review risk assessment reports and ensure implementation of scientifically justified risk mitigation strategies.
• Assist organizations in strengthening quality systems through compliance-driven solutions.
• Review and provide guidance on validation programs including Process Validation, Cleaning Validation, Analytical Method Validation, Equipment Qualification, and Computer System Validation.
• Ensure documentation aligns with regulatory expectations and industry best practices.
• Review analytical data, stability studies, laboratory investigations, and method validation reports to ensure accuracy, compliance, and data integrity.
• Support clients in responding to regulatory authority queries, deficiency letters, and compliance notices.
• Provide strategic regulatory guidance throughout the product lifecycle including development, approval, and post-approval changes.
• Monitor emerging regulatory guidelines, pharmacopeial updates, and industry best practices.
• Provide internal knowledge sharing and advisory inputs to ensure clients remain compliant with evolving regulatory expectations.

Preferred Candidate Profile

• Educational Qualification: Masters or Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or related discipline.
• Strong experience in Pharmaceutical Quality Assurance, Quality Control, or Regulatory Affairs.
• Demonstrated experience in GMP audits, compliance assessments, and regulatory documentation review.
• Hands-on experience with Quality Management Systems (QMS) including deviation handling, change control, investigations, and CAPA management.
• In-depth knowledge of GMP guidelines, pharmacopeial standards, and regulatory requirements.
• Ability to review analytical data, risk assessments, investigation reports, and stability data.
• Strong understanding of data integrity principles and regulatory inspection expectations.
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities with a compliance-focused approach.
• Ability to interpret complex regulatory guidelines and translate them into practical solutions.
• Strong communication and presentation skills for client interaction.
• High level of integrity, professionalism, and attention to detail.
• Ability to work independently as well as in a collaborative consulting environment.
• Willingness to travel across India for client audits and inspections.
• Flexibility to work on multiple assignments and tight regulatory timelines.
• Proficiency in Microsoft Office and digital documentation tools.