Team Member - QA QMS

Team Member - QA QMS

Roles & Responsibilities:

• Handling of QMS activities like change control, Deviations, CAPA, Market complaints Recalls and Returned goods as per the predefined procedure product as per procedure.
• To involve in Regulatory filings and query response.
• To access Cross site applicable CAPA at site.
• To ensure compliance of SOP for closure of Deviations within timelines.
• To carryout Deviation/Market Complaint/CAPA trends as per procedure.
• To involve in the Management of Risk Assessments and Risk Summary.
• Review of all logbooks used in Production, Packing, Quality Control, Engineering & Warehouse area.
• Ensure the compliance in the manufacturing facility or area with respect to the cleanliness, and labelling as per the cGMP.
• Responsible to carry out the investigations and timely closure of the same within the time line.
• To involve in QRM and Tracking actions periodically.
• To Carry out any other job assigned by the Head of the Department, Quality Assurance.
• To carry out the Document life cycle management as per the approved procedure and applicable software’s.
• Annual Product quality review.
• To participate in handling of internal and external audits (Customers/Regulatory agencies). Coordinate with plant QA for preparation of response and appropriate CAPA.
• Responsible to evaluate the gaps, with respective to current regulatory expectation and observations in pharmaceutical industry.
• Initiation and handling of Quality Notification of Deviations, CAPA, OOS & OOT/FAR/QDN/Recall and Change controls through applicable software’s.
• Review of change controls through as per applicable software.
• Responsible for participation in the investigations i.e. OOS, OOT, Deviations and ensure its closures within the timelines.
• Periodic review of the area, equipment and the instruments are in validated and calibrated state.
• Review of SOP’s, Protocols, Reports, Qualification documents, Deviations/OOS/OOT/Market Complaints/Recalls/FAR/QDN.
• Responsible for co-ordination with RA for Data Submission.
• Responsible for maintaining the licenses and Quality Technical Agreements and communication to SCM and RA personnel for license updation.

Qualifications

• Educational Qualification

• Graduation in Pharmacy

• Minimum Work Experience

• 8+ years of experience.

• Skills & Attributes Functional Skills

• . Change Control Coordinator

• Market complaint investigator

• APQR

• Resident Skills

• Current Good Manufacturing Practices (cGMPs)

• 21 CFR Part 210 and 211

• Behavioural Skills

• Technical leadership – guides teams in solving complex challenges and driving automation excellence.

• Continuous improvement mindset – fosters a culture of proactive problem-solving, learning, and cost-effective innovation.

• Critical Exposures

• 8+ years in roles across QMS systems and Market Complaint investigations

• Additional Information

• Benefits Offered

• At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs.

• The benefits you will enjoy at Dr. Reddy’s 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. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t 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 we’re 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 https://careers.drreddys.com/#!/"