Job Description

Overall Job Purpose:

• The QA Manager is responsible for ensuring compliance in all Sun Pharma\'s biological (CMO) manufactured externally worldwide. This includes ensuring compliance and oversight of analytical quality control related activities of biologics products managed and released by the Quality Assurance CMO unit while ensuring market compliance of QC methods, specifications and stability programs. The QA manager shall oversee stability programs, release testing results and maintain appropriate quality oversight of Contract Service Providers/laboratories. The QA manager shall ensure support for on time release of relevant products and appropriate maintenance of local quality systems related to Analytical. He/she ensures that activities at Contract Manufacturing/service Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement and with the marketing authorizations.

Major tasks & responsibilities:

• Maintain oversight and management of stability studies executed by the testing labs, including preparation/review of stability protocols, raw data and review/preparation of reports while ensuring proper follow up at the testing site of timely execution of testing plans as per scheduled time points.
• Liaise with external Analytical testing lab for ensuring testing of GMP analytical samples in accordance with approved specifications while maintaining as well oversight of on time testing and execution of stability sample testing.
• Skilled in trouble shooting and support in investigations.
• Creation, review and maintenance of testing analytical methods and specification ensuring compliance with validation studies and with the marketing authorizations while ensuring proper communication with the testing labs upon receipt or generation of change controls affecting approved analytical methods or relevant specifications.
• Preparation, review and assessment of routine trending of stability data collected for new and annual stability programs and ensuring immediate notification to the Quality team/QP in case of observed trends or suspected out of specifications.
• Support/author analytical technical assessment as required for supporting deviation investigation or other relevant studies.
• Support with preparation of PQR from QC perspective in regards to continuous analytical trending and assessment of analytical data.
• Support the maintenance and update of QA/QC quality management system.
• Support the timely implementation of global standards and procedures in the local units by execution of associated GAPs assessments against local procedures.
• Act as initiator and reviewer of local standards to ensure timely and appropriate review and approval of controlled documentation part of the QMS.

• Perform timely review in accordance with the MA and with the approved analytical method of QC analytical data originated at the testing site and timely preparation and issuance of COAs used for batch certification by the QP.
• Act as SME during evaluation and review of product related change controls, deviations, out of specifications, complaints, regulatory queries, method transfers and analytical method validations in regards to analytical testing, and quality control of drug substance, intermediates drug products & finished products. The QA manager shall author scientifically sound deviation investigations and assessments and recommends effective corrective actions as appropriate.

Key Performance Indicators/result areas

• On time review of analytical data, preparation of CoA and support for timely batch release
• In time management and closure of significant quality events, change controls, complaints, deviations etc.)
• On time preparation of APR/PQR.
• On time receipt and review of stability testing for each time point. Timely issuance of stability testing CoA.
• On time assessment and implementation of Global procedures into local system.

Qualifications, Knowledge, Experience & SkillsEducation Qualifications (Graduate- Post Graduate)Mandatory

• MSc in chemistry/biotechnology/life science/pharmaceutical field.

Work experienceMandatory

• Minimum 6 years of experience in quality control, analytical QA.
• Direct experience with Bioanalytical test methods/bioassays tests, analytical (e.g HPLC) test, extended characterization, microbiological testing.
• Knowledge and understanding of cGMP regulations and good documentation and laboratory practices
• Fluent in English.

Preferred

• Additional experience in drug product sterile pharmaceutical manufacturing is an asset.
• Experience as QA is an asset
• Fluent in English. German is an asset

Technical skills/job specific competencies

• Advanced knowledge and experience in bio pharmaceutical operations, QC processes, critical reagent qualifications, Development and contract manufacturing.
• Strong cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU and other international agencies)
• Experience with quality systems.
• Experiences with eDocument Management, Training systems and Trackwise
• Strong cGMP and GDP experience and knowledge, QA/QC and regulatory compliance (US, EU and other international agencies)
• Strong understanding of risk assessment and risk management fundamentals/tools
• Needs good knowledge of MS office and Windows based computer applications.

Behavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)

• Strong interpersonal skills, excellent communication skills, good presentation, negotiations and influencing skills
• Ability to effectively manage multiple, complex priorities.
• Team player, task oriented and keen on working in a cross-cultural working environment.

Sun Pharmaceutical Industries