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Microbiologist - Pharmaceutical Industry

The company:

A well established Australian owned Pharmaceutical contract manufacturer located in Mulgrave. This large facility contains an R&D Department, large state of the art manufacturing plant, warehousing and logistic solutions, workforce of 250+ people to ensure clients requirements are met on-time and to their strict requirement guidelines.

Due to the contract manufacturing nature of this business there is plenty of variety and experience that can be gained as well as a career path for the tenacious and team focussed individual.

Responsibilities of the role:

The role is responsible for timely testing of food and pharmaceutical products in accordance to the TGA and NATA approved methodology. The role also involves reporting of results, client liaison, new method development and validation.

Testing includes:

• Sterility testing and validation
• Endotoxin testing and validation
• Pharmaceutical testing
• Laboratory maintenance reagent preparation

To be successful in this role you must possess:

• 2+ years of laboratory experience in a similar role within the food, beverage or pharmaceutical manufacturing industry
• Degree with a Microbiology Major and/or equivalent
• Good aseptic technique in laboratory practice
• High level of analysis and skills in laboratory methods and operations
• Diligence in documentation of data and attention to detail
• A solid understanding of microbiological outcomes and results
• Proven ability to work as part of a team where duties/tasks are on roster
• Sound knowledge of general laboratory safety

It is advantageous if you possess some of the below:

• Understand the principles of Good Manufacturing Practices (GMP) and Good Laboratory -Practices (GLP)
• Have knowledge of Microsoft Office software

This position has been filled, but openings for this type of position come up very frequently. We highly recommend to Register Your Interest below so that you will be the first to know when the next position opens up.

IMPORTANT: It is a requirement of all our jobs that you have a PR or AU/NZ Citizenship. A work visa is not sufficient as all our jobs are permanent. Please do not apply if you do not meet these requirements.

Register Interest

• Perform comprehensive quality control testing on raw materials, in-process samples, and finished pharmaceutical products using various analytical techniques (e.g., HPLC, GC, spectroscopy).
• Analyze test results, interpret data, and prepare detailed reports.
• Identify and investigate any out-of-specification (OOS) results or deviations from established procedures.
• Develop and validate analytical methods according to regulatory guidelines (e.g., ICH, USP).
• Ensure all laboratory activities comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Maintain accurate and organized laboratory records, including experimental data, results, and instrument calibration logs.
• Participate in internal and external audits, providing necessary documentation and explanations.
• Collaborate with R&D, Production, and Regulatory Affairs departments to resolve quality issues and implement process improvements.
• Stay updated on current pharmaceutical industry regulations, guidelines, and best practices.
• Contribute to the continuous improvement of quality systems and laboratory operations.
• Train and mentor junior laboratory personnel.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• Minimum of 4-5 years of experience in a pharmaceutical quality control or quality assurance role.
• Extensive hands-on experience with analytical instrumentation such as HPLC, GC, UV-Vis, FT-IR, and dissolution apparatus.
• Thorough understanding of GMP, GLP, and relevant regulatory guidelines (ICH, USP, FDA).
• Proficiency in data analysis and interpretation, with strong problem-solving skills.
• Excellent attention to detail and accuracy in all work performed.
• Strong written and verbal communication skills.
• Ability to work effectively in a team environment and collaborate across departments.
• Familiarity with LIMS (Laboratory Information Management System) is a plus.
• Knowledge of stability testing protocols is desirable.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• Minimum of 3 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of GMP, regulatory requirements (e.g., FDA, EMA), and quality management systems.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Proven ability to work independently and manage multiple tasks in a remote setting.
• Proficiency in data analysis tools and software.

• Perform analytical testing on raw materials, intermediates, and finished products.
• Utilize analytical instrumentation such as HPLC, GC, and spectroscopy.
• Ensure compliance with GMP, GLP, and relevant regulatory standards.
• Maintain and calibrate laboratory equipment and instruments.
• Develop and validate new analytical methods as needed.
• Investigate deviations, out-of-specification results, and market complaints.
• Prepare Certificates of Analysis (CoA) and maintain accurate laboratory records.
• Participate in internal and external audits.
• Contribute to quality improvement initiatives.

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field.
• Minimum 5 years of experience in pharmaceutical quality control/assurance.
• Proficiency in analytical techniques (HPLC, GC, spectroscopy).
• Strong understanding of GMP and GLP regulations.
• Experience with method development and validation is preferred.
• Excellent documentation and record-keeping skills.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team.

• Ensure compliance with GMP, ICH, and other relevant regulatory guidelines.
• Review and approve batch manufacturing records and quality control data.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints.
• Develop, implement, and maintain Corrective and Preventive Actions (CAPA).
• Perform validation of analytical methods and equipment qualification.
• Conduct internal audits and support external regulatory inspections.
• Analyze stability data and contribute to stability study protocols.
• Prepare and review technical reports and regulatory submission documents.
• Participate in quality risk management activities.

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or a related life science field.
• Minimum of 6 years of experience in pharmaceutical quality assurance or quality control.
• In-depth knowledge of GMP, regulatory requirements, and quality management systems.
• Experience with analytical method development and validation.
• Strong understanding of pharmaceutical manufacturing processes.
• Excellent data analysis, problem-solving, and report-writing skills.
• Proficiency in relevant software and quality management systems.
• Ability to work independently and manage multiple priorities in a remote environment.

Despatch Clerk - Mulgrave - Pharmaceutical Industry

We are seeking a Despatch Clerk for a Mulgrave based Pharmaceutical Manufacturer.

To be a successful applicant, following requirements need to be met:

• Must have 3 - 5 years experience in a similar role
• Dangerous goods handling experience and training
• Chemical handling experience and training
• High level computer literacy
• High reach forklift licence
• Australian/NZ Citizenship or Permanent Residency Status
• Car and Licence
• Live in close proximity of the south eastern suburbs

IMPORTANT: It is a requirement of all our jobs that you have a PR or AU/NZ Citizenship. A work visa is not sufficient as all our jobs are permanent. Please do not apply if you do not meet these requirements.

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