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- Responsible to maintain the laboratory as per good laboratory practices, good documentation practices, 21 CFR guidance and meets cGMP Requirement.
- Responsible to adhere with data integrity policy, ALCOA++ principle during performing any activity inside the company premises.
- To follow the administrative policies including personal hygiene, HR procedures, environmental and safety regulations within the site premises.
- To identify unsafe conditions/ acts inside the laboratory, report to supervisor/ HOD- QC and ensure its completeness.
- Responsible to keep Lab and Instruments neat, clean and in working condition all the time.
- Timely communicate any abnormalities observed during analysis and escalate it to supervisor for appropriate action.
- To ensure the analysis activity perform in the laboratory by following approved procedures.
- To ensure the training on the activity which are assigned by supervisor/ HOD-QC prior to execution.
- Actively involve and Participate in assessment, investigations, and implementing CAPA effectively.
- Responsible for Internal & External vendor follow-up and timely completion.
- Responsible for maintain the minimum stock and Use valid working standards, reference standards, impurity standards, chemicals, reagents, glassware and solvents required for analysis and Ensure availability as and when required.
- Perform Sampling & analysis of packing materials, raw materials, stability samples, in process and finished products.
- Responsible to perform and complete the work assigned by supervisor / HOD-QC / Head-Quality as and when required.
- To receive the analysis sample includes packing materials, raw materials, In-process, Intermediate, API, Finished product samples and make entry in to the respective AR number logs.
- Responsible for analysis of test parameters includes description, solubility, Water content, Purity/ related substances by GC, Assay by GC etc.by using approved testing procedure.
- To execute the analysis activity by completing all necessary documentation related to instrument logbooks, analytical test report, analysis worksheets, analytical hard books and document archival after approval of samples.
- To perform the wet lab instrument calibration as per the schedule and respective SOP as and when required.
- To perform the GC instrument calibration as per the schedule and respective SOP and qualification of GC instruments as and when required.
- To execute the chemical analysis of additional studies like stability study, method validation/ verification study/ any investigation purpose analysis.
- Destruction of samples after approval and subsequent record to be updated.
- To ensure the availability of valid working standards, impurity standards, reference standards and its management during usage.
- To Support to maintain GC columns within the laboratory and ensure the stock availability.
- Report any non-conformance i.e. Laboratory Incidence, OOS/OOT/OOC to Immediate supervisor for further action.
Department: Quality ControlLocation: DigwalJob Overview: To perform Quality Control actives as per GMP & SafetyTravel Requirements: NA
Reporting Structure
Reports to Manager - QC
Key Stakeholders
Internal: Production, QA, SCM, IT, Engineering & Maintenance, TSD & SafetyExternal: Customers
Experience
- 4-8 Year Experience in Quality Control Chemical and Instrumentation Analysis for In-process, Stability, Raw Materials, Working standard/Reference standard, Packing Materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC (API) as per Pharma Manufacturing GMP requirements.
Responsibilities
Key Roles & Responsibilities
- Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPIC.
- Responsible for allotting the work to the chemist within the QC department.
- Responsible for performing the calibrations of all instruments in QC as per the schedule.
- Responsible for maintaining all the documentation online.
- Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required.
- Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis.
- Responsible for keeping instruments neat and clean and overall housekeeping in the FP section.
- Responsible for review of analytical data, calibration data, qualification data.
- Responsible for keeping all instruments within the calibrated status.
- Responsible to do the analysis, review and release on time to support the production.
- Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues.
- Responsible for real time data monitoring.
- Responsible for reviewing the analytical data received from external laboratory.
- Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates.
- Responsible for maintaining the consumption records and traceability of working/reference standards.
- Responsible for OOS investigations, deviations and CAPA implementations
- Responsible for review of SOP’s , test procedures and specifications
- Responsible for providing the training on GLP/GMP to the employees working the section.
- Responsible for releasing the batches timely manner to achieve the site requirement.
- Responsible for preparing the COA’s as per the customer requirement
- Responsible for approving/rejecting the batches in SAP
- Responsible for Controlling the cost and operate within the approved budget.
- Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments.
- Responsible for carrying out the analytical method transfers, Method validations, Method equivalency study and Method verification activities.
- Responsible for keeping the critical spare parts of the instruments.
- Responsible for Safe working conditions and clean environmental practices.
- Responsible for usages of required safety appliances in the section.
- Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches.
- Responsible to train the contract persons and helpers on glassware cleaning.
Qualifications
B.Sc (Chemistry) / M.Sc (Chemistry) / B. Pharmacy / M. Pharmacy
Required Skills
GC & Wet analysis handling
About Us
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The Team
Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders.PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators.Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space.Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment.Job Info
- Job Identification 8977
- Job Category Quality Control
- Posting Date 07/14/2025, 06:25 PM
- Apply Before 08/14/2025, 06:25 PM
- Degree Level Bachelor's Degree
- Job Schedule Full time
- Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN
