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.

- Robust 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 cooperative 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.

📌 Assistant Manager - Pharmaceutical Quality Assurance (Chandigarh)
🏢 Vaayath Consulting Services
📍 Chandigarh