Amneal Pharmaceuticals is a leading global generic pharmaceutical company, with a focus on developing, manufacturing, and marketing high-quality, affordable medications for patients worldwide. Founded in 2002, the company has operations in the United States, India, and Ireland, and has a portfolio of over 1,000 generic and specialty products across various therapeutic categories. Amneal is committed to improving access to healthcare through its mission to make medicines accessible to all.
IPQA EM (Environmental Monitoring) department for Amneal Pharmaceutical Pvt. Ltd (Injectable units, SEZ – Matoda Plant, Ahmedabad)
INJECTABLE REQUIREMENTS:
In-Process Quality Assurance (IPQA) Department- (Injectable/Parenteral Unit)
IPQA stands for In-Process Quality Assurance. It is a quality control process that is implemented during the manufacturing of a product to ensure that it meets the required quality standards. IPQA involves inspecting and testing of the product at various stages of the production process to identify and resolve any quality issues before the final product is released. The aim of IPQA is to prevent defects, improve product quality, and reduce the risk of product recalls. It is a critical step in ensuring that the end product meets the required standards for safety, efficacy, and overall quality.
Designation: Trainee / Officer/ Sr. Officer
Qualification: M.Sc (Micro) / B. Tech. (Biotech.) / M. Tech (Biotech)
Experience: 0 to 04 years (Only Male candidates required)
Shift Type: Rotational Shift timing
Job Responsibilities:
- Environmental monitoring of manufacturing clean room area
- Non-viable particle monitoring of manufacturing clean room area.
- Compressed air /nitrogen gas monitoring and Personnel monitoring.
- To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc.
- To perform line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labeling and packing.
- To perform Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP.
In the pharmaceutical industry, IPQA (In-Process Quality Assurance) refers to the activities carried out by personnel to ensure that the manufacturing process is in compliance with the established standards and guidelines.
A typical IPQA job role in the pharmaceutical industry may include the following responsibilities:
- Monitoring and inspecting the manufacturing process to ensure that it is in compliance with Good Manufacturing Practices (GMPs) and other relevant regulations.
- Performing in-process testing and inspections, such as checking for product uniformity, weight, and packaging, and verifying that batch records are complete and accurate.
- Conducting process validations, such as equipment calibration, process capability studies, and process performance qualification.
- Monitoring and reporting deviations from established standards and protocols.
- Collaborating with production teams to resolve quality issues and implement corrective actions.
- Assisting with the preparation and review of standard operating procedures (SOPs) and other quality control documents.
- Maintaining up-to-date knowledge of GMPs, regulatory requirements, and industry best practices.
- Participating in internal and external audits.
- Performing other duties as assigned by the management.
Note: This is just a general list of responsibilities and the specific duties of an IPQA role may vary
A candidate with good communication & interpersonal skills, computer knowledge, and an understanding of regulatory requirements will be preferred.
APPLICATION PROCESS; Interested candidates can share their CVs on ajaykumar.pandey@amneal.com by mentioning the subject “Application for IPQA EM Department” or can refer suitable other candidates for this job opportunity.
COMPANY LOCATION; Amneal Pharmaceuticals, No. 15, Pharmez (Special Economic Zone – SEZ Highway, Matoda, Sarkhej-Bavla Rd, Sanand, Gujarat 382213
Tel: (0)2714677533
Mobile: 9664900548, 9727761565