Quality Specialist III - Night Shift

Teva Pharmaceuticals; Bengaluru; On-site; INR 450,000 - 750,000; Full time

Job summary

Teva Pharmaceuticals Bengaluru is seeking a complaints handling professional for night shift support. You will receive, log, trend and coordinate sample returns for quality-related issues, acting as SME for intake processes and ensuring proper documentation for high-profile cases.

You will contribute to QAS improvement, support audits, and provide data on complaints, deviations and CAPA as needed. Fluency in English and willingness to work night shifts are essential.

Qualifications

• Experience handling complaints in a regulated environment.
• Knowledge of cGMP and CFR concepts preferred but not mandatory.
• Strong written and verbal English communication skills.

Responsibilities

• Process complaints by receiving, logging, trending and coordinating sample returns.
• Coordinate with QAS Intake team and act as SME for intake processes.
• Manage high profile complaints with proper justification and documentation.
• Support continuous improvement, audits and data reports for QAS.
• Handle voice process calls with Teva customers during shift.

Skills

Complaint handling

Night shift

English communication

QMS knowledge

Data analysis

Education

B.Pharm / M.Pharm / MSc

Tools

TrackWise

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)