Dr. Reddys Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products Dr. Reddys offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, and differentiated formulations.
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The major therapeutic focus is on gastrointestinal, cardiovascular, diabetology, oncology, pain management, and anti-infective. Major markets include India, USA, Russia-CIS, and Europe apart from other select geographies within Emerging Markets. For more information, log on to www.drreddys.com
Position: Group Lead – Quality Control
Location: Hyderabad, Telangana
- Ensure lot release of commercial & stability batches; respond to regulatory queries and while ensuring that the organizational quality systems are followed on the shop floor; prepare monthly reports on trends and observations & plan for resources and infrastructure for short and long term sustainability, Review SOP /STP
- Preparation as per the GLP/GMP Guidelines, lead investigations, able to frame and justify procedural and systemic changes using the tools under the QMS guidelines and ensure closures of all documentation in a timely & scientific manner with the objective of ensuring that the highest standards of quality are adhered to by the staff and resources of the facility
Roles and Responsibilities
Ensuring Quality in testing & documentation:
Train motivate and provide resources to the team members to enable testing & release of all samples with adequate documentation as defined in the quality systems of biologics IN ORDER TO release batches in a timely manner with the adequate manner of safety & quality
Co-ordinate with Lab Support team to attend to breakdown and troubleshooting of instruments; co-ordinate with SCCAE for maintenance engineers; take supervisor assistance in case of delayed response from SCCAE IN ORDER TO ensure that all instruments of the facility are in good working condition and adhere to quality standards
Train and qualify new and existing analysts; conduct regular training planned by audit & compliance team; monitor and review resource availability to analysts and analysts’ performance; assign JDs to analysts and check progress; allot work to analysts; review and approve analysts’ work allotment books; IN ORDER TO ensure that analysts are trained and deliver the highest quality of work.
Conduct repeat analysis in case of QA queries/customer complaints; prepare and submit the report for supervisor approval and QA submission; conduct repeats analysis and provides support for queries from regulatory; IN ORDER TO ensure that all queries received by QC are handled, and closed in time.
Prepare and discuss the monthly report on analysts’ performance; prepare a monthly report of products handled and discuss turnaround time; prepare a monthly report on instruments’ utilization and OOS/OOT/incidents; monitor night shifts; IN ORDER TO provide information on highlights/lowlights of the team and facility performance, and ensure that GLP guidelines are adhered to.
Conduct goal setting, performance appraisals and mentoring/coaching for own team members; collaborate with HR in manpower planning, recruitment activities, and identifying training needs of team members; provide training to team members on new processes when required IN ORDER TO maximize retention and performance of team members.
Desired Candidate Profile
Expertise in data interpretation from chromatography, electrophoresis, Molecular Biology with a keen eye for investigation of failures. Very good understanding of GMP systems
Education & Experience :
M. Tech/M Sc/Ph.D. in Biotechnology or related fields with 10 – 13 years of work experience in various fields on QC.
Knowledge: Regulatory guidelines; ICH guidelines; Pharmacopoeia
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