HPLC Reviewer | Ozone Pharma | Gurgaon

Job Description

Ozone Pharmaceuticals is urgently hiring for the role of HPLC Reviewer for its Analytical Lab based at Bhondsi, Gurgaon.

Job Summary:

To plan and prioritize, sample, test, and release test reports of products to strict timescales, in order to support the business requirements.

Key Responsibilities:

• 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