Senior Executive QA – (E3 Grade)*

From 7 to 12 year(s) of experience
₹ 6,00,000 - 9,00,000 P.A.
Posted: 2 days agoOpenings: 2Job Applicants: 2308+Job Views: 7594+

Job Description

Review of the BMRs, Quality control, Production, Warehouse and Maintenance records/Logs.

Handling and review of Change Control, Deviation and Incidents.

Preparation of APQR and preparation of online trends.

Monitoring the line clearance activities at plant area

Having experience in handling of regulatory audits i.e. USFDA, MHRA, TGA, CDSCO, WHO etc.

Adherence to SOPs and cGMP Compliance through monitoring on line

Ensuring proper handling, storage & monitoring of inventories as per SOP

Knowledge on process validation and cleaning validation.

Perform annual physical verification of all control samples to ensure their viability Participate in risk assessment meetings

Knowledge on Deviation, CAPA, Change Control and Quality Risk Assessment studies.

Preparing and Reviewing the process validation protocols & reports.

Preparation & Standardization of volumetric solutions and leading the Internal Audits.

Investigation writing skills and know about its tools.

Knowledge on CAPA effectiveness monitoring and evaluation.


Know about current practices i.e. cGMP, regulatory guidelines and current requirements.

Ability to train the employees in the routine QA activities, Quality E applications and SOPs.

Have experience in internal, customer and Regulatory audits

Good communication and presentation skills


Designation & Grade : Senior Executive - E3

Location: Visakhapatnam



Role:Other

Salary: 6,00,000 - 9,00,000 P.A.

Industry:Pharmaceutical & Life Sciences

Functional Area:Other

Role Category:Other

Employment Type:Full Time, Permanent

Education

UG:B.Sc in Any Specialization

PG:MS/M.Sc(Science) in Chemistry

Doctorate:Doctorate Not Required

Company Profile

LUPIN LIMITED

Lupin Limited is one of India's largest manufacturers of bulk actives and formulations. The principal bulk actives manufactured by it include Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives) and cardiovasculars. The company also possesses competencies in phytomedicines, in which medicines are made out of plant and herbal resources supported by the discipline of modern medicine.
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