Team Lead Cleaning Validation- Manufacturing Science & Technology (MSAT OSD at Dr Reddy's Laboratories Limited

Hyderabad, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cleaning Validation, Good Manufacturing Practices, SOP Preparation, Risk Assessment, Analytical Research, Communication Skills, Interpersonal Skills, Problem-Solving, Team Collaboration, Training, Digitalization, Technical Protocols, Swab Sampling, Quality Management System, Regulatory Compliance, Surface Area Derivation

Industry

Pharmaceutical Manufacturing

Description

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 Job Summary We are looking for a detail-oriented individual to lead the implementation of cleaning validation procedures and protocols, ensuring compliance with regulatory standards and Good Manufacturing Practices (GMP). This role involves preparing and reviewing SOPs, validation plans, and reports, contributing significantly to the quality management system and regulatory compliance efforts within the organization. Roles & Responsibilities • You will be responsible for preparation, review, and approval of Cleaning Master Validation Plan, Cleaning Validation and Verification Protocols and Reports, Acceptance Criteria documents, Cleaning Validation matrix, and Periodic Monitoring Schedule. • You will be responsible for implementing and complying with the cleaning validation SOP (Standard Operating Procedure) and the Cleaning Validation master plan. • You will assist in preparation and review of SOP, Operating Instruction, Standard Cleaning Procedure. • Your responsibilities include compiling cleaning validation reports by summarizing reported data, updating periodic monitoring schedule as required, and providing support in identifying hard-to-clean locations and deriving surface area for contact parts. • You will track and manage execution of cleaning validation activity. • You will also review and approve QMS (Quality Management System) documents such as incidence reports, change controls, etc. • You will be accountable for ensuring that validation activities are carried out according to the protocol and in compliance with cGMP (Current Good Manufacturing Practices), cGxP (Current Generally Accepted Practices) and regulatory requirements. • Your role extends to assisting preparation and review of risk assessments, URS (User Requirement Specification) and Design Qualification documents related to cleaning validation activities. • You will be expected to participate in internal and external audits, providing explanations of cleaning validation related documents to auditors and inspection teams. • You will be responsible for QMS management, including initiation, approval and closure of change controls, incidents, audit compliance and impact assessment. • For all cleaning validation related activities, your role involves providing support to internal and external stakeholders, providing training to personnel, and participating in digitalization and simplification of activities. Qualifications Qualifications Educational qualification: Bachler of pharmacy / master’s in science / pharmacy Minimum work experience: 8-13 years of experience in Cleaning Validation Skills & attributes: Technical Skills Experience in the execution of cleaning validation activities for products in Solid dosage forms. Experience in Swab sampling activities. Ability to prepare technical protocols and reports. Experience in risk assessment approaches. Knowledge of PDA Tech report 29, ISPE, APIC and other relevant guidelines. Familiarity and proficiency in using CLEEN software. Experience in Analytical Research and knowledge on interpretation of the data. Behavioural Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Performance oriented and good at building, leveraging relationship. Ability to work collaboratively with own team and cross-functional teams. Committed to Learning & Coaching the team. Additional Information About the Department IPDO/Global Manufacturing Organisation (GMO) At Dr. Reddy's 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 state-of-the-art 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 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. 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. 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/#!/ Job Family: Research & Development Sub Job Family: R&D - General Preferred type of working: On-Premise Years of Experience: 6 - 12 Business unit: IPDO

Responsibilities

Lead the implementation of cleaning validation procedures and protocols, ensuring compliance with regulatory standards and Good Manufacturing Practices. Prepare and review SOPs, validation plans, and reports while contributing to the quality management system.