Piramal Pharma Limited
Location
Dhar | India
Job description
The Team Lead, Quality Control (QC) will be responsible for leading a team of Quality Control Chemists.
In this role, you will be responsible for the following tasks:
Ensures that Quality Control activities are conducted in compliance with Current Good Manufacturing Practices.
Ensures that methods are followed, and that documentation is complete and accurate.
Ensures that team s testing is completed timely to support operations requirements.
Ensures that test data are accurate when
data meets specification, submits completed test record and supporting data to Quality Assurance for release
test results do not meet specification, initiates an Out-of-Specification investigation, pursuant to ASI SOP, and, based upon the results of the investigation and appropriate follow-up, submits completed records and recommendations to QA for final disposition.
Acts as the primary source for training of Quality Control Chemists on the team.
Responsible for scheduling of resources for release testing, In-process testing, analytical cleaning verification, evaluation studies and qualification/requalification of analytical reference standards.
Trouble shooting analytical method issues and instrumentation issues.
Assists in review of team s data.
Initiate and perform change controls for SOP, test method or specification forms
Experience:
Minimum B.S. in Science (Chemistry, Biochemistry, etc, with emphasis on analytical chemistry).
8-15 years in pharmaceuticals QC.
Thorough knowledge of analytical instrumentation.
Thorough knowledge of GMP.
Ability to work independently and solve problems.
Required Skills and Competencies:
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
Minimum B.S. in Science (Chemistry, Biochemistry, etc, with emphasis on analytical chemistry).
8-15 years in pharmaceuticals QC.
Quality Control Testing, Planning and Scheduling:
Collaborate with Operations to ensure timelines are met.
Collaborate with Project Managers to ensure FPs release timelines are met.
Testing of raw materials, starting materials, intermediate products, final products, and cleaning verification samples.
Testing of In-Process Control samples.
Assesses resource requirements (equipment, testing materials, and labor) and schedules resources to support operations need for timely testing and release of raw materials, starting materials, intermediates, and final products and for timely testing and confirmation of cleaning verification samples.
Ensures that testing is conducted as per written procedure or compendial method to comply with ASI requirements, client requirements and regulatory requirements, including CGMP and safety requirements.
Ensures that Chemists test reports are accurate through thorough review of test records and laboratory notebooks. Included in this dimension is the investigation of Out-of-Specification incidents. Ensures that logbooks, related to analytical instrument use and maintenance, retain sample storage, etc., are completed timely and accurately.
Supervisory Responsibilities:
Recognizes the need for urgency in the responsibilities and makes attempts to meet all requirements and deadlines.
Takes initiative to identify and correct any weaknesses in the current ASI systems.
Is reliable with respect to accuracy and completeness of work.
Is reliable with respect to attendance schedule, on-time arrival and diligent work ethic throughout the day.
Manages teamwork load, drives accountability, and provides direction as needed.
Ensures proper shift hand-off communication to the other Shift Supervisor and the QC Manager.
Initiate and write deviations in conjunction with analyst(s)
Manage team members in terms of approving timecards, performance evaluations
Maintain laboratory housekeeping per ASI SOP
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