Complaints Investigator

Position Summary

The Complaints Investigator is responsible for conducting thorough, timely, and compliant investigations of product quality complaints. This role evaluates manufacturing, packaging, testing, and distribution data to determine root cause, identify trends, and ensure alignment with regulatory expectations and company quality standards. The investigator ensures documentation accuracy, data integrity, and effective communication with internal and external partners.

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Essential Job Responsibilities

Complaint Evaluation & Investigation

· Monitor complaints in-box.

· Initiates and completes investigations for all types of complaints.

· Requests retain testing in accordance with complaint(s), as applicable.

· Reviews and analyzes batch records, product release summaries, test data, variance investigations, and other relevant documents to determine relationship to the reported complaint.

· Differentiates between Product Quality Complaints, Adverse Events, and Product Inquiries and routes/escalates accordingly.

· Escalates complaints requiring priority handling or urgent investigation.

· Concisely summarizes investigation results and conclusions in written reports consistent with GMP and procedural requirements.

System Use & Documentation

· Performs all investigation-related data entry into the Customer Complaint Database (TrackWise).

· Generates reports from the TrackWise, evaluates output for accuracy, and ensures data integrity.

· Ensures all closed complaints are forwarded to appropriate clients/business partners.

· Revises SOPs and Work Instructions (WI) relevant to complaint handling, investigation, and documentation processes.

Metrics, Trends & Reporting

· Performs metrics for assigned product categories and evaluates complaint data for trends.

· Assists in routine monthly or periodic metrics reporting.

· Identifies potential issues or recurring trends requiring escalation or corrective action.

Cross-Functional & External Collaboration

· Works closely with contractors, clients, and business partners to maintain open communication and support investigation activities.

· Collaborates with cross-functional internal teams such as Manufacturing Sites, respective QA, QC, Regulatory Compliance, and Supply Chain.

· Serves as a contributing member of the team to achieve departmental and company outcomes.

Compliance & Ethical Conduct

· Ensures all investigation activities comply with cGMPs, FDA regulations, internal policies, and quality standards.

· Operates in accordance with the company’s Code of Conduct, Business Ethics, and all applicable regulatory, compliance, and safety requirements.

· Performs all work in support of the company’s Values.

· Performs special projects and other duties as assigned.

Job Requirements

Education (replace with India relevant requirements).

• Diploma in Pharmacy (D.Pharm), Bachelor of Pharmacy (B.Pharm), B.Sc. in Life Sciences, Chemistry, Microbiology, Biotechnology, or related scientific discipline with 1–3 years of relevant pharmaceutical industry experience; OR

• Higher Secondary Certificate (12th Standard) with 3–6 years of related pharmaceutical manufacturing, quality, complaints handling, QA/QC, or GMP experience and/or training.

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Knowledge, Skills & Abilities

· Knowledge of FDA regulations and cGMP requirements related to complaint evaluation and adverse reaction assessment for pharmaceutical products.

· Understanding of pharmaceutical processes, principles, and practices.

· Strong written and verbal communication skills, including grammar, punctuation, and business English.

· Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access), email systems, and internet research.

· Experience with QMS systems such as TrackWise, relevant/similar system.

· Ability to work independently with minimal supervision, using sound judgment to accomplish goals.

· Strong organizational skills with the ability to manage multiple tasks, adapt to change, and meet deadlines.

· Ability to apply common-sense understanding to carry out written, oral, or diagram instructions.

· Ability to solve problems involving several concrete variables in standardized situations.

· Ability to read and interpret procedure manuals, operating instructions, and safety rules.

· Ability to write routine reports and professional correspondence.

· Basic mathematics skills, including ability to calculate percentages, means, modes, medians, and perform operations with money, weights, volume, and distance.

· Ability to speak effectively with customers, business partners, or internal staff.

· Strong interpersonal skills and ability to maintain cooperative working relationships.

· Commitment to compliance with all company policies, procedures, and safety regulations.

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Experience

· Prior experience in complaint handling and/or direct experience in investigations, corrective action processes, or related activities within Quality Control, Quality Assurance, Regulatory Compliance, Manufacturing, or related pharmaceutical disciplines.