Executive-qc

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 Control

Location: Digwal

Job Overview: To perform Quality Control actives as per GMP & Safety

Travel Requirements: NA

Reporting Structure:
Reports to Manager - QC

Key Stakeholders:
Internal: Production, QA, SCM, IT, Engineering & Maintenance, TSD & Safety

External: 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.

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.

Piramal Critical Care (PCC), under Piramal Pharma Limited (PPL),