Section Head - Quality Assurance

• Investigation of OOS OOT & Incidents  
• Ensuring CAPA implementation and effectiveness.
• Handling of customer and support in regulatory audits.
• Review and approving of validation and qualification protocols & reports.
• Handling of market complaints and review of associated investigations ensuring the timely closure of the complaints.
• Handling to return goods review of associated investigations and ensuring appropriate closure of the return goods.
• Handling of product recall and mock recalls as per schedule
• Review and approval of change notifications.
• Carrying assigned Selfinspection as per the schedule and ensure its correction corrective and preventive actions are taken.
• Review and approval of quality risk assessments.
• Ensure training activities are carried out as per SOP
• Monitoring and ensuring CQT activities and regulatory submissions
• Review of SOPs
• Monitor the team activities
• Review and approval of CAPA OOS Incidents trends
• Coordination for the site level quality management review and preparation of data for the QRM meetings and escalation of quality concerns as identified with Site Leadership team.  
• Handling of vendor qualification.
• Complete the selftraining and monitor the training of team members on relevant SOPs.
• Review of Annual Review Reports.
• Authorized for approval of phase 1/ 2 & LIMS task w.r.t OOS/OOT/hypothesis study/reanalysis / retesting /resample once relevant investigation approved by QA Head or Quality Head.
• Authorized for approval of validation protocols reports SOPs and specifications in absence of QA head/ Quality head or based on instructions from QA head/ Quality head.
• Any other responsibility as assigned by HOD

Qualifications :

Educational qualification: A Graduate or Postgraduate in pharmaceutical science

Minimum work experience: 12 years of experience in QA in pharmaceutical industry preferably with shop floor experience

Skills & attributes:

Technical Skills

• Thorough understanding of the pharmaceutical industry including its regulatory framework quality standards and market dynamics.
•  Knowledge of regulatory requirements for pharmaceutical manufacturing processes like technology transfer manufacturing and commercialization.
• Familiarity with international regulatory guidelines established by the International Council for Harmonization (ICH).
• Ability to interpret and apply ICH guidelines related to drug development including those concerning quality safety efficacy and regulatory submissions.
• Proficiency in quality management systems validations (process cleaning) audits handling response drafting. 

Behavioral skills
Proficient in effectively allocating and utilizing resources to optimize productivity and achieve goals.
Strong leadership qualities to inspire and motivate team members towards common objectives fostering collaboration and innovation.
Capable of efficiently managing time to prioritize tasks meet deadlines and maintain productivity levels.
Possesses excellent verbal and written communication skills to convey ideas instructions and information clearly and effectively.
Analytical thinking to assess situations identify problems and develop strategic solutions contributing to informed decisionmaking processes.

Additional Information :

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence we are a leading force in the pharmaceutical industry.
We operate 19 stateoftheart manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardiovascular Central Nervous System and AntiDiabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.

Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at !/ 

Remote Work :

No

Employment Type :

Fulltime