Senior Executive – Quality Assurance
Job Title : Senior Executive – Quality Assurance
Number of Positions : 1
Experience : 3-5 years
Location : Hyderabad
Job Type : Full Time
Company: BioPulse Solutions Pvt Ltd
Industry : Pharma Equipment Manufacturing
About BioPulse Solutions
-
BioPulse Solutions Private Limited is India’s first open architecture, single-use bioprocessing and
engineering solutions provider and integrator for fluid-handling applications. Our team of experts
specialises in biopharmaceutical domain and has 100+ years of combined experience in providing unique
fluid handling solutions for complex biopharma applications.
BioPulse Solutions has been founded with a vision of “Enabling Solutions for a Better Tomorrow”. Our goal is to address critical challenges in the biopharma processes by integrating technology innovations and customised solutions to our customers processes.
To know more, visit : www.biopulsesolutions.com
If you have excellent communication and interpersonal skills, as well as Compliance awareness and the ability to think strategically, a career in Quality could be for you.As an Jr. Executive, you will act as a thinker who should be able to develop and execute plans for the resulting successful implementation of quality standards and to provide professional advice to the organization.
You will be required to do the following
- Preparing the strategies for the implementation of Quality standards for QC/Microbiology/Quality Assurance and Quality Management Systems.
- Establish & maintain working relationship with the people working in the office.
- Co-ordinate activities with regards to Quality and Compliances.
- Submit individual promotional plans
Job Responsibilities
- Hands on experience in Technology Transfer, VMP, Validation matrix design, Quality Manual, Site Master File, Safety Manual, Calibration Manual, Procedures, Supportive, forms and Analytics.
- Quality management system, Design and Execution: Layout design and detailed engineering, Validation of facility, water system, equipment, method, process, Cleaning validation, Computer / electronic System validation, Change control, Deviation, OOS, OOT, Investigation, CAPA, Maintenance and Preventive maintenance, Stability testing, Quality Control, Batch Control and Product release, Documentation system, Product recalls, Internal Quality Audit – self inspection, Complaint Handling, Risk Analysis, APQR, Vendor qualification, EM & Water Quality monitoring, Training, Designing of system according to various country specific regulatory guidelines.
- Organising continuous audits to ensure compliance and sound functioning of the process.
- Reviewing and revising the technical specifications / batch manufacturing record / validation protocols, validation reports, SOPs, Protocols, Test reports and other GMP documents.
- Generating analytical specifications for raw materials, intermediates and finished goods together with the Analytical and Regulatory Group.
Requirements & Skills
- Good Organization skills and leadership skills and attention to detail.
- A “Can do approach” to work and a strong sense of commitment towards work
- Good communication skills and command of spoken and written English
- Very pleasing and friendly personality.
- Attitude of counsel and advice.
- Constant updating of information relating to various guidelines etc.
- Willingness to work long hours and unsociable hours whenever necessary
Qualifications
- Postgraduate in any Life Sciences/Chemical Sciences
Experience
- Min. 3-5 years in similar capacity in a reputable organizatio