- Date Posted22/09/2022
- Expiration date--
- Experience5 Years, 7 Years
- Desired QualificationMaster’s Degree
- Salary in (₹)5,00,000 - 7,00,000
Ozone Pharmaceuticals is urgently hiring for the role of HPLC Reviewer for its Analytical Lab based at Bhondsi, Gurgaon.
To plan and prioritize, sample, test, and release test reports of products to strict timescales, in order to support the business requirements.
- Prepare SOPs/procedures/formats and amend/revised them from time to time as and when required, ensure all SOPs are up to date, make/amend a list of SOPs and share with all employees along with the new version number.
- Planning and prioritizing samples and samples allotment to analysts.
- Provide training to new joiners and make them familiar with the system and technology.
- Developing and validating methods for testing of raw materials, intermediates and finished products, existing products on the stability program, and cleaning validation exercises.
- Sampling and testing of raw materials, intermediates, and finished products using current pharmacopeias, any associated wet chemistry, and instrumental techniques (HPLC, IR, UV), as appropriate.
- To support preparing Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (COA) (for finished products), and stability reports.
- Creating and executing method development and method validation test protocols for finished products and generating the appropriate analytical methods.
- To support for Stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques, as appropriate.
- Writing analytical specifications using current pharmacopeias and reviewing existing analytical specifications. Writing/reviewing Standard Operating Procedures (SOPs).
- To support the GLP team in calibrating analytical equipment, as and when required.
- Supporting all QC activities.
- To support GLP Team for validation of analytical equipment as and when required.
- To support for validation of the master excel sheet used for analytical calculation.
- To ensure the full compliance of 21 CFR in the analytical equipment used in the analytical laboratory.
- To support and raise the lab requirement and coordinate with the purchasing team if required.
- Ensuring that procedures are carried out carefully and accurately to eliminate errors.
- Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.
- Working with all members of staff to maintain and develop the positive progressive culture within the Laboratory.
- Observing and complying with Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good documentation practices, Good laboratory practices, and Good review practices.
- Observing and complying with Data Integrity in the laboratory.
- Observing and complying with company Health and Safety Policies.
- Observing and complying with company Standard Operating Procedures (SOPs).
- Undertaking any other duties, which may be requested, defined by the line Manager, for which training and/or an explanation has been provided and understood.
Desired Candidate Profile:
- Post Graduate in Chemistry or Pharma will be preferred
- Minimum 5 – 7 yrs of experience in Analytical / Commercial Lab
- Male candidates will be given a higher preference
- Must know how to provide data review
Work Location: Analytical Lab, Village – Bhondsi, Gurgaon.
Qualification: MS/M.Sc Chemistry