Quality Specialist III - Night Shift

Teva Global Business Services; Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Benefits offered by this job

Hybrid working (3 days in office, 2 at

Job summary

Teva Global Business Services seeks a Complaint Processing Associate to manage intake, logging, and coordination of product quality complaints across phone, email, and web channels.

The role acts as SME for QAS intake processes, ensures SOP compliance, and supports continuous improvement initiatives. Night shifts and hybrid office-work are part of the schedule, withpreferred USal usage, and a focus on regulatory adherence.

Qualifications

• Bachelor or Master of Pharmacy degree required.
• Understanding of CFR and cGMP is helpful but not mandatory.
• Experience with product quality complaints and adverse events beneficial.

Responsibilities

• Handle receipt, logging, and coordination of product quality complaints from multiple channels.
• Act as SME for intake processes and ensure SOP compliance.
• Perform day-end reviews for high-profile complaints and support continuous improvement initiatives.

Skills

Communication skills

English proficiency

Night shift readiness

Regulatory/compliance awareness

Education

B.Pharm

M.Pharm

MSc (pharmacy)

Tools

TrackWise

QAS Intake system

Job description

Role & responsibilities

• Complaint Processing:
• Performs the functions associated with receiving, trending, logging and coordinating the return of the Samples for product quality related Complaints. This includes complaints received via phone, email, and internet. Utilize knowledge and experience from processing of live complaint calls to lead by example.
• Assists QAS Intake team management in handling of QAS Intake team activities :
• Serves as a Subject Matter Expert on all In-Take Team complaint processes and scenarios and assists QAS employees to ensure compliance with Quality Assurance Services Standard Operating Procedures and Work Instructions. Collaborate with QAS Daily review team and/or closing team to discuss and calibrate on varying views on how records should be handled.
• Responsible for handling High Profile complaints. Conduct a day end review to ensure that proper justification is provided for and documented in all High Profile complaints.
• Participate and contribute to the continuous improvement activities of the QAS group:
• Participate in the continuous improvement of the QAS Group to drive operational excellence by performing a variety of tasks and projects to increase compliance, efficiencies and effectiveness of actions within the Group. Tasks and Projects may include but are not limited to:
• Support audits and inspections of QAS group
• Provide data related to product complaints, volumes, Deviation reports as required
• Identify automation and defect proofing opportunities and highlight the same to QAS management via business cases, quantifiable data.
• voice process (Incoming and outgoing calls to various customer's of Teva)

Preferred candidate profile

• Minimum 1-4years of overall experience in Complaints handling,
• Bachelors degree of Pharmacy (B. Pharm) or Master’s Degree in Pharmacy (M. Pharm) and also MSC if candidate is fitting in criteria required
• Understanding of US Code of Federal Regulations (CFR), Current Good Manufacturing Practices (cGMP) but not mandate
• Understanding of Product Quality related Complaints and Adverse Events; Deviations/Investigations/Root Cause Analysis, CAPA; Data Integrity and TrackWise but not mandate.
• Excellent written and verbal communication skills in English Language
• Flexibility to work in continuous permanent night (6:30 PM to 2:30 AM IST)
• Availability to take phone calls with external customers continuously during the US business hours
• Experience from regulated market preferred
• Shift: Night Shift (6 PM to 3 AM)
• Hybrid Working (3 Days working from office and 2 days working from home)