Section Incharge - RPHPLC (API Peptide)

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

• To oversee all operations in Production area in accordance to the established SOPs and cGMP and capture the data in relevant documents.
• Responsible for the operation, maintenance, and troubleshooting of RPHPLC equipment.
• Responsible for the operation, maintenance, and troubleshooting of dynamic axial compression (DAC) columns.
• To complete the assigned trainings in Talent Hub and ensure respective team members are completed their trainings in Talent Hub.
• To follow the intermediate area & Clean Room practices as per defined SOPs.
• Ensuring that the production facilities are clean and maintaining high standards of housekeeping.
• To ensure that material packed as per the Order Process Document and hand over the material well before EDD.
• Ensure that all measuring instruments/equipment are calibrated.
• Investigating product failures/deviations and ensure taking necessary correction, corrective and preventive actions within target timeline.
• Review the qualification documents, Protocols, SOPs and relevant documents.
• Qualify the new/modified facilities and equipment before use.
• Provide Training to all personnel on GMPs & Safety and production related activities.
• Production Planning ensure that the batches are produced as per plan.
• Improve plant environmental conditions as per SHE regulations.
• To ensure the equipment safety and process safety by following Safety guidelines and wearing the PPE during the execution of production activities.
• Ensuring that equipment’s are released for preventive maintenance in a safe manner and ensuring cleanliness before and after preventive maintenance activity.
• To attend the cGMP training and internal training [SOPs, Process Parameters, cGMP and Operational safety etc.] classes.
• To complete the trainings in iLearn and ensure respective team members are completed their trainings in iLearn.
• Bill of materials (BOM) and recipe maintenance in SAP.
• To review the PSI, PHA, PSSR and safety related documents.
• Ensure to procure Raw materials from Ware house as per requirements.
• Ensure the entry of batch related details consumption in SAP.
• To ensure Trial / Process Performance Qualification batches as per the specific steps mentioned in the concerned Protocol.
• To ensure the Equipment Cleaning & Area Cleaning as per the specific steps mentioned in the concerned ECRs & Protocol.
• To Initiate & follow the Change controls & Incidents, timely follow the closure of CCFs, OOS, OOT & Incidents.
• Participating in product reviews and recommending product for process improvements.
• Safe disposal of waste products as per established procedures.
• Ensure proper utilization of equipment and manpower.
• Monitoring the stocks.
• Maintaining discipline at the work place and solving the employee grievances and to release Internal Communication to the production blocks for information sharing as per the requirement.
• To give specific instructions to the subordinates for accomplishing the day-to-day activities.
• To report any near miss incidents to the concerned and report the Process / System deviations to Quality Assurance through a relevant document and to involve, investigate and implement the corrective actions.
• Reviewing batch production records (BPRs), Ensuring that are completed and handover BPRs to Quality Assurance within the stipulated time as per SOP.
• To undertake any other job as may be assigned by the concerned production in-charge / Department Head (Production).

Qualifications

Educational qualification: Bachelor's in Engineering/ B.Tech/ preferably chemical Engineering
Minimum work experience: 13 to 17 years of experience, preferably in a manufacturing environment with a focus on cGMP compliance and regulatory audits
Skills & attributes:
Technical Skills
• Experience in Production Planning, Handling Manpower,
• Knowledge on GMP & Documentation, Delivery Management.
• Knowledge of maintenance planning for machines, and the proficiency in compiling and analysing daily, weekly, and monthly reports for leadership review.
• Regulatory audit leadership and experience in handling international Regulatory Audits.
• Familiarity with safety norms and the implementation of EHS policies.
• Budgeting skills for preparing and effectively executing departmental budgets.
Behavioural skills
• Leadership and managerial skills to manage and evaluate subordinate staff.
• Strong communication and coordination skills for interdepartmental collaboration and smooth day-to-day activities.
• Commitment to nurturing talent and motivation through training programs.
• Detail-oriented mind set for ensuring adherence to specifications, SOPs, and quality policies.
• Strategic thinking and goal alignment for effective organizational development.

Additional Information

About the Department
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/#!/