Section Head - Quality Assurance for Oral Solid Dosage (OSD) Manufacturing

Dr Reddys Laboratories; Solan; On-site; INR 4,000,000 - 7,000,000; Full time

Benefits offered by this job

Relocation support

Maternity & Paternity benefits

Learning & development opportunities

Medical coverage for you and family

Life insurance

Job summary

Dr. Reddy’s Laboratories Ltd. in India seeks a Section Head QA – OSD to lead in‑process QA and ensure cgmp compliance across OSD formulation manufacturing.

You will drive data integrity, review BMR/BPR, support validation, manage deviations and CAPA, and mentor a QA team to deliver Right‑First‑Time quality in a fast‑paced environment. You will guide analytical QA activities, ensure methods meet SOPs and pharmacopeial requirements, and collaborate with cross‑functional teams to sustain regulatory

Qualifications

• B.Pharm / M.Pharm / M.Sc in relevant discipline required.
• 15+ years QA experience in OSD formulation manufacturing.
• Minimum 2–3 years in a senior executive / team leadership role.
• Exposure to AQA, OOT and OOS investigations.

Responsibilities

• Lead IPQA activities for manufacturing and packaging operations with real-time QA oversight.
• Review BMRs/BPRs, in-process checks, and critical process parameters for compliance.
• Manage line clearance, batch initiation, and batch closure activities.
• Uphold ALCOA+ data integrity and support validation and technology transfer batches.
• Lead deviations, OOS/OOT investigations and CAPA effectiveness checks.
• Drive root cause analysis and participate in change controls and risk assessments.
• Oversee Analytical QA activities: review data from materials, in-process, finished products and stability.
• Ensure analytical methods meet SOPs, specs, and pharmacopeial requirements.

Skills

IPQA

AQA

OOS/OOT investigations

CAPA & RCA

Change control

Data integrity

QA leadership

Education

B.Pharm / M.Pharm / M.Sc (Chemistry or relevant discipline)

Job description

Section Head QA – OSD Company Description

Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait. We started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries. For nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity – to strengthen our core further (the next steps) and to build the future (the new bets). ‘The Next and the New’ is how we aim to continue to be the partner of choice – purpose‑driven, future‑ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose – helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency Dr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.

Job Description Role Purpose

To lead In‑Process Quality Assurance activities for OSD formulation manufacturing, ensuring cGMP compliance, data integrity, inspection readiness, and Right‑First‑Time execution, in line with Quality Management System and global regulatory expectations.

Key Responsibilities

• IPQA – Manufacturing & Packaging
• Ensure real‑time QA oversight during dispensing, granulation, blending, compression, coating, ampoule and packing operations.
• Review and ensure compliance of BMRs/BPRs , in‑process checks, and critical process parameters.
• Manage line clearance, batch initiation, and batch closure activities.
• Ensure adherence to ALCOA+ principles and data integrity requirements.
• Support process validation, cleaning validation, and technology transfer batches.
• Investigations & Quality Management Systems
• Lead and support deviations, OOS/OOT, incidents, and market complaints (if applicable).
• Drive root cause analysis (RCA) and ensure robust CAPA implementation and effectiveness checks.
• Participate in change control, risk assessment, and continual improvement initiatives.
• AQA – Analytical Quality Assurance
• Review and approve analytical data related to raw materials, in‑process, finished products, stability, and cleaning samples.
• Ensure compliance with analytical SOPs, test methods, specifications, and pharmacopeial requirements.
• Review and support investigations related to OOS, OOT, atypical results, laboratory incidents, and method-related deviations.
• Ensure data integrity compliance in QC laboratories, including audit trails, CDS, LIMS, and manual records.
• Review method validation, method transfer, and analytical change control documents.
• Participate in stability program review, trend analysis, and analytical risk assessments.

Qualifications

• Educational Qualification B.Pharm / M.Pharm / M.Sc (Chemistry or relevant discipline)
• Experience 15+ years of experience in QA – OSD formulation manufacturing
• Minimum 2–3 years in a senior executive / team leadership role
• Exposure to AQA, OOT and OOS Investigation

Experience Level Senior Level

Experience Level Senior Level

Additional Information

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.

Benefits Offered

• 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/#!/