Lead Executive - EMQ Customer Complaint

Apotex; Mumbai; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Apotex is seeking a Quality Systems Specialist to ensure GMP and regulatory compliance for third-party manufactured products and those supplied under contract. You will interact with RA, New Product Launch, Supply Chain, Sales & Marketing and other Quality groups to support Customer Complaint Management and the Annual Product Quality Review.

The role requires strong cGMP knowledge, documentation control, and collaboration with external partners to uphold global quality standards and internal

Qualifications

• Bachelor's degree in science or a College Diploma in Pharmaceutical Technology, or a related field.
• Strong knowledge of global cGMPs (HC, FDA and EU) and QA/QC systems.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent organizational, analytical, and interpersonal communication skills.
• Ability to work independently or as part of a team.
• Proven ability to build strong relationships with third-party partners.

Responsibilities

• Handle customer complaints for products manufactured by third parties according to the customer complaint process.
• Maintain complaint logs and acknowledge complainants.
• Escalate critical complaints to Global External Manufacturing Quality on the same day.
• Review APRs and assist in product compliance file assessment.
• Support development of SOPs for External Quality.
• Coordinate documentation control and archiving of External Quality documents.
• Update External Quality database for third party manufacturers.
• Adhere to Global Business Ethics, Quality and HR policies and safety procedures.
• Collaborate as a team member to achieve outcomes.
• All other duties as assigned.

Skills

Global cGMPs knowledge

Detail-oriented

Multi-priority management

Organizational skills

Analytical thinking

Inter-personal communication

Independent / team player

Stakeholder relationships

Leadership & accountability

Education

Bachelor's degree in science or College Diploma in Pharmaceutical Technology

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

Microsoft PowerPoint

SAP

TrackWise

Job description

Job Summary

Responsible for execution of Quality Systems to ensure that Apotex meets its regulatory and GMP compliance obligations for Third Party manufactured products and products supplied by Apotex under contract to Third Party Organizations. This includes Quality Systems to support Customer Complaint Management and Annual Product Quality Review. Interact with internal groups involved in Third Party Operations (e.g., RA, New Product Launch, Supply Chain, Sales & Marketing and other Quality groups).

Job Responsibilities

1. Responsible for handling Customer Complaints for products manufactured by Third Parties according to the Customer Complaint process.
   • Manages the receipt of incoming customer complaints.
   • Triaging of all incoming complaints.
   • Logs complaint details into customer complaint system and sends out Acknowledgement Letter to complainants.
   • Notify the Third-Party manufacturer of incoming complaints.
   • Tracks investigation progress by Third Party manufacturer.
   • Review Third Party Investigation Report to ensure that complaint was satisfactorily investigated and adequate CAPA identified.
   • Close complaints and sends out Response Letter to complainants.
   • All non-critical complaints that are identified as Critical (during investigation outcome or new information) must be escalated to Global External Manufacturing Quality on same day.
   • All critical complaints with known problem type but not limited to (e.g., Leaking PFS, Red spot on SGC, Solubility & Precipitate).
2. Review the final APR using vendor s APR and Apotex s APR and submit it to Manager in Canada for final approval.
3. Assists in the development of processes for Product Compliance File assessment and gap closure. Provides support to Regulatory Affairs & Corporate Quality on internal requests for information held at Third Party Manufacturers.
4. Supports in the development of SOPs to ensure efficient and compliant External Quality functions.
5. Coordinates a centralized documentation control system for External Quality. Coordinates the routing for review, issuance and archiving of External Quality controlled documents.
6. Updates and maintains the External Quality database for Third Party Manufacturers.
7. Works in a safe manner collaborating as a team member to achieve all outcomes.
8. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
9. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
10. All other duties as assigned.

Job Requirements

• Education
  • Bachelor s degree in science or a College Diploma in Pharmaceutical Technology, or a related field.
• Knowledge, Skills and Abilities
  • Strong knowledge of Global cGMPs (HC, FDA and EU) and the QA/QC systems associated with the manufacture of human drug products.
  • Detail-oriented, accurate and reliable.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Superior organizational skills, analytical thinking and inter-personal communication skills.
  • Ability to work independently or as part of a team.
  • Ability to build strong working relationships with Third Party partners.
  • Demonstrates personal leadership and accountability.
• Experience
  • At least 5-6 years of progressive Quality experience in QA or QA/QC roles.
  • Experience with Microsoft Computer Products (Word, Excel, Access, PowerPoint).
  • Experience with SAP and TrackWise is an asset.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.