Associate Manager, Quality Control (Manufacturing)

Description:

This role prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, and SOPs applicable to laboratories, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities, commits and delivers as committed.

Essential Functions:

• Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities; assignments shall be in writing and a day in advance.
• Drives effective and efficient shop floor supervision enforcing compliance to data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, LNB, log book, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
• Initiates OOS/OOAL investigation, participates in investigation activities, and closes in the books when approved, in a timely manner. Prepares reports of investigation, method transfers, method verification/validation where required. Ensures implementation of CAPA, as identified during the investigations.
• Ensures timely testing and releases of raw materials, in-process, finished products, stability samples from the lab. Reviews and approves, COA, stability summary reports, investigations, APR trend data, calibrations, qualifications, and other analytical records as needed.
• Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol,and specification) applicable to quality laboratory.
• Reviews changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.
• Has all laboratory personnel complete weekly worksheet, reviews worksheets with respect to schedules, and submits completed worksheets. Involved in day-to-day laboratory testing and helps analysts as and when needed.
• Reviews method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identifies training needs and provides necessary training to the analysts as and when needed.

Additional Responsibilities:

• Participates in analysis as and when required for special projects. When required, summarizes data for in-process testing, testing and release of finished products, and stability data for trending.
• Attends production planning meeting and updates list with delivery dates committed, track delivery dates with respect to committed dates. Submits a list containing weekly samples-in and out.

 

Education:

• Bachelors Degree (BA/BS) Chemistry or related technical field - Required
• Master Degree (MS/MA) Chemistry or related technical field - Preferred

Experience:

• 7 years or more in Pharmaceutical Laboratory (With Bachelors)
• 2 years or more in Supervisory Experience (With Bachelors)
• 5 years or more in Pharmaceutical Laboratory (With Masters)
• 2 years or more in Supervisory Experience ( With Masters)

Skills:

• Must be precise and consistent in laboratory data interpretations with respect to USP general chapters and applicable FDA guidance, easily trainable, ready to learn, thorough in reviewing and evaluating laboratory data with respect to established specifications. - Advanced
• Must have a thorough understanding of analytical chemistry and analytical techniques used in a laboratory setting. Must be able to effectively communicate results, problems or issues, verbally as well as in writing. Must be able to identify and trouble shoot problems arising during the course of execution of approved methods. - Advanced
• Must be able to supervise and lead a team of about 6 to 10 team members, Must be able to assume a role of leader in a team environment and be flexible to easily adapt to the changes in assignments given by laboratory or Quality Management. - Intermediate
• Must follow safe practices as identified in appropriate MSDS during working with chemicals, and must follow and enforce applicable state and federal regulations, e.g, OSHA. - Advanced
• Must be well versed with Microsoft Office programs, computer literate, and be able to communicate both verbally and in writing. - Intermediate
• Must be thoroughly familiar with cGMP applicable to laboratories in pharmaceutical testing environment. Must be able to ascertain and enforce compliance to specifications, methods and SOPs in a day-to-day supervision, including laboratory setup and cleanliness. - Advanced

Specialized Knowledge:

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC).Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.Must understand and apply cGMP requirements applicable to quality control laboratory.Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.Must be able to identify trends in analytical data.

Licenses:

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.--

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.