Executive - Quality Control

piramalpharma

Digwal

On-site

INR 600,000 - 900,000

Full time

7 days ago

Be an early applicant

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Piramal Critical Care is seeking an Executive - Quality Control to uphold laboratory quality systems, data integrity, and regulatory compliance. The role covers sampling, testing of materials, and ensuring adherence to cGMP and LAB policies.

The incumbent will execute analyses and support CAPA investigations within the QC function. The position requires a BPharm and familiarity with GLP, 21 CFR guidance, and stability studies.

Qualifications

Bachelor of Pharmacy (BPharm) required.
Good Documentation Practices and cGMP knowledge preferred.
Stability studies and raw materials knowledge beneficial.

Responsibilities

Maintain the laboratory per GLP, documentation practices, 21 CFR guidance and cGMP requirements.
Adhere to ALCOA++ data integrity principles in all activities.
Follow site HR procedures, environmental and safety regulations.
Identify unsafe conditions and report to supervisor/ HOD-QC.
Keep lab and instruments clean and functioning; notify abnormalities promptly.
Ensure analyses follow approved procedures and proper training.
Participate in CAPA assessments and investigations.
Coordinate with internal & external vendors; ensure timely follow-up.
Maintain stock of standards and supplies; manage sampling and control samples.
Perform sampling and analysis of materials and finished products.

Education

Bachelor of Pharmacy (BPharm)

Tools

Job description

Division

Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Executive - Quality Control Job Description

Quality Control Analyst for Executive Position.

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 for keep Lab and Instruments neat, clean and in working condition all the time.
Timely communicate any abnormalities observed during analysis and escape 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
Responsible for sampling activity and Control sample Inspection.
Perform Sampling & analysis of packing materials, raw materials, stability samples, in process and finished products.
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.
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.
To initiate the analysis as per work allocation done by supervisor/ HOD-QC of these samples for test parameters includes description, solubility, Water content and other chemical analysis and non-Chromatographical methods of wet laboratory section.
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 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.
To preparation of dispatches COA's i.e RM,PM API, IMT and Finished etc..