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.
- Vacancy details:
- Department: Team Member Qualification
- Qualification: M.Pharm
- Experienced: 9+ years
- Salary: ₹Not Disclosed
Job Description: Greetings from Dr. Reddy’s Laboratories Ltd. .!!
- Important Details :
- Location: Pydibimavaram
- Post of date:17/08/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Job Summary
We are looking for an individual for the qualification team to manage the documentation and execution of qualification activities, including the preparation, review, and execution of various qualification documents. The ideal candidate will oversee new project-related tests, review and compile raw data, and ensure compliance with validation master plans and SOPs. Additionally, responsibilities include implementing corrective and preventive actions, conducting incident investigations, and providing support during regulatory inspections.
Roles & Responsibilities
• You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents.
• Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems.
• You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).
• You will review and compile raw data, relevant certificates, analysis test reports and
• preparation and review of final summary report.
• You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation.
• Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval.
• You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification.
• As part of your role, you will prepare and review VMP (Validation Master Plan).
• You will conduct training for employees and external vendors as a qualified trainer.
• Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label.
• You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment.
• You will also provide necessary assistance and support to various regulatory, internal and external inspections.
Educational qualification: An M.Pharm.
Minimum work experience: 9+ years of experience
Skills & attributes:
Technical Skills
• Experience in working with sterile product facility related validations such as equipment validation, media fill, cleaning validation, process validation, area qualification, and other miscellaneous qualifications.
• Expertise in preparation, review, and execution of documents, including URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ.
• Experience in Handling incident investigations and CAPA processes.
• Experience in preparation and review of VMP and SOPs.
Behavioural Skills
• Effective communication skills for conducting training sessions and qualification activities.
• Attention to detail for preparing and reviewing documentation and reporting.
• Application of problem-solving skills in incident investigations and CAPA implementation.
• Efficient time management for meeting qualification schedules.
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/#!/
- Vacancy details:
- Department: Team Member – QA
- Qualification:A Bachelor’s degree in Pharmacy, MSc,Chemistry, MSc Microbiology Chemical Engineering, or a related field
- Experienced: 3 to 7 years
- Salary: ₹Not Disclosed
Educational qualification: A Bachelor’s degree in Pharmacy, MSc,Chemistry, MSc Microbiology Chemical Engineering, or a related field
Minimum work experience: 3 to 7 years of experience in pharmaceutical manufacturing or a similar role
Skills & attributes:
Technical Skills
• Knowledge of microbiology and aseptic practices, cleaning validation activities, sampling and relevant standards.
• Proficiency in performing line clearance, material verification, start-up checks, and in-process checks following batch manufacturing and packing records.
• Experience in timely sampling and testing of in-process, reserve, and finished samples, as well as stability samples and environmental monitoring.
• Skilled in reviewing batch manufacturing and batch packing records, ensuring accuracy and certification after execution.
