Quality Control Associate Compliance

The QC Compliance Specialist ensures that all quality control operations comply with internal procedures and external regulatory standards. This role is pivotal in managing documentation driving continuous improvement and maintaining audit readiness.

Key Responsibilities

Change Control Management:

o Initiate evaluate and track change controls related to QC processes instrumentation and documentation.

o Ensure proper impact assessments and timely implementation of approved changes.

STP and SOP Revisions:

o Review revise and maintain Standard Test Procedures (STPs) and Standard Operating Procedures (SOPs) to reflect current practices and regulatory updates.

o Collaborate with QC analysts and QA to ensure clarity accuracy and compliance in documentation.

CAPA Oversight:

o Support investigation and closure of Corrective and Preventive Actions (CAPAs).

o Ensure root cause analysis and effectiveness checks are properly documented.

QMS Tracking and Documentation:

o Maintain Quality Management System (QMS) records including deviations investigations and audit findings.

o Monitor and report status of quality events to ensure timely resolution and compliance.

Timeline Adherence:

o Track due dates for all quality system activities and ensure no overdue items.

o Escalate delays and coordinate with stakeholders to meet regulatory and internal deadlines.

Audit and Inspection Support:

o Prepare documentation and participate in internal and external audits.

o Ensure readiness and compliance with applicable standards.

Gemba Inspections:

o Conduct routine GEMBA walks to observe QC operations directly at the source.

o Identify gaps in compliance documentation and execution through real-time observation.

o Document findings and follow up on corrective actions to ensure closure and effectiveness.

Qualifications :

Qualifications

Bachelors degree in Life Sciences Chemistry Microbiology or related field.

47 years of experience in a regulated QC or QA environment.

Familiarity with GMP ISO standards and regulatory expectations (e.g. FDA EMA).

Hands-on experience with Quality Management Systems (QMS) for tracking CAPAs change controls deviations and document revisions.

Proficiency in QMS platforms (e.g. LIMS DocHub Qualex SAP. Fyori....) and document control systems.

Strong attention to detail organizational skills and ability to manage timelines effectively..

Behavioural Skills

• Self-starter.
• Team player.
• Excellent oral and written communication skills.

Additional Information :

About the Department

Integrated Product Development Organisation

We integrate our deep science capabilities and cutting-edge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions for patients globally.

We have end-to-end capabilities in:

• API (Active Pharmaceutical Ingredients)
• Formulations
• Clinical
• Intellectual Property
• Regulatory Affairs

We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from:

• Active pharmaceutical ingredients (API)
• Oral formulations
• Parenteral (Injectables Ophthalmics)
• Other dosages

Our product development efforts drive a portfolio of more than 1000 products. Enabled by our robust R&D team consisting of over 200 scientists and functional experts including more than 150 doctorates we have filed 1071 patents and published over 1000 papers for peer review over the years.

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:

• 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 also 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. 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 Work :

No

Employment Type :

Full-time