1 Opening(s)
8.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 15.00 LPA
Key Responsibilities:
Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
Lead QC team operations, daily task allocation and technical troubleshooting.
Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
Manage stability studies, instrument calibration, analytical method validation/transfer and ...
1 Opening(s)
18.0 Year(s) To 25.0 Year(s)
40.00 LPA TO 48.00 LPA
Amoli Organics Pvt Ltd - GM Engineering -Vadodara.
Unit turn over 450 cr. (Company turn over 1200 + Cr)
Team :- 50 + Offrole
CTC :- 40 TO 48 LPA (All fixed) - Age max 50..52 Yrs
Note :- Source only from Pharma API Plant. Look for someone who is leading the engineering Dept.
...
2 Opening(s)
3.0 Year(s) To 5.0 Year(s)
Not Disclosed by Recruiter
IPQA activities, Plant round, Online BMR review, Line clearance, Samplingof APIs, Analytical data review, Batch release, APQR preparation. People who have faced regulatory audits like EDQM would be givenpreference.
Process & cleaning validation, including cleaning matrix preparation
QMS documentation management; SOP preparation, review, and training
IPQA activities
to ensure GMP compliance during manufacturing.
Regulatory inspection exposure ...
1 Opening(s)
20.0 Year(s) To 25.0 Year(s)
18.00 LPA TO 22.00 LPA
Good Knowledge of USFDA/ EDQM /ANVISA / and all other regulatory & CGMP awareness.
Strategic oversight and leadership: Develop and implement the company's quality management system (QMS) and strategy, aligning it with business objectives. This includes overseeing all aspects of quality operations and managing the QA and QC departments.
Regulatory compliance: Ensure ...
1 Opening(s)
10.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 15.00 LPA
ompile, author, and maintain Type III Drug Master Files (DMF) for the US FDA, Health Canada, and equivalentregulatory submission dossiers for European (EDQM) and Asian regulated agencies.Coordinate the preparation of comprehensive technical dossiers covering raw materials, master-batchcompounding matrices (Halobutyl polymers), formulation ingredients, and vulcanization traits.Manage the swift completion of annual ...
1 Opening(s)
9.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 14.00 LPA
A Quality Assurance (QA) Manager for a Starch Powder Active Pharmaceutical Ingredient (API) or excipient manufacturing plant oversees cGMP compliance, quality management systems (QMS), process validations, and regulatory audits tailored to pharma-grade modified or native starches used as excipients/APIs.
Job Title: Quality Assurance Manager
Industry: Pharmaceutical API, Excipients & Starch Powder Manufacturing
Reporting ...
5 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 6.00 LPA
Key Responsibilities:
Documentation Management:
Review, approve, and control various quality documents, including Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packing Records (BPRs), Specifications, Test Procedures (STPs), and other quality-related documentation.
Ensure proper archiving, retrieval, and revision control of all controlled documents.
Participate in the preparation and review of site master files (SMF), ...
1 Opening(s)
8.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 20.00 LPA
Key Responsibilities:
1. Production Planning & Execution Management: * Assist the Production Manager in developing and implementing daily, weekly, and monthly production schedules to meet demand forecasts. * Allocate resources (manpower, equipment) effectively to optimize production efficiency. * Oversee and monitor the execution of all production activities as per Batch Manufacturing ...