Title:  Senior Manager - Quality Control

Title:

Business Unit:

QC

Job Grade

Location :

Ahmednagar

Key Responsibilities

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

JOB SUMMARY:

• To ensure on handling of documents like analytical test procedures, specifications, standard operating procedures from initiation till implementation.
• To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment.
• To ensure sampling activities are performed as per SOP and sample integrity are maintained till analysis completion.
• To ensure working/reference standards are made available for analysis and timely qualification of standards within due date.
• To involve in investigations and to collaborate with cross function team for root cause determination and implementation of effective CAPA.
• To ensure safety and use of required personal protective equipment’s during day-to-day activities.
• Responsible for carrying out any other responsibilities assigned from time to time orally or in writing by HOD.
• To maintain and enhance quality index of the site unit data elements pertaining to QC function.
• Identify the training need and organize for the training to concerned group in QC to avoid event and unconfirmed OOS due to errors during analysis.

ESSENTIAL JOB FUNCTIONS:

• To ensure stability samples are charged and analysis completed within the due date and stability chambers are monitored and maintained at respective conditions.
• To ensure effective analytical methodology are placed for testing.
• To ensure analytical method validation and analytical method transfer activities are completed and validated methods are adopted for testing.
• To ensure sampling activities of RM/Intermediates/Finished as per approved standard operating procedures.
• To ensure stability study sampling, stability study chamber monitoring and timely withdrawal and completion of analysis.
• To review the analytical method validation, method transfer, regulatory submission related documents, working reference standard procurements.
• To co-ordinate self-inspection (internal audit) and its compliances.
• To approve the lab event/out of specification/our of trend/our of calibration/CAPA/change control/deviation.
• Ensure trend of quality control errors and effective CAPA implementation.
• To monitor the compliance with the requirement of GMP.
• To participate in the management reviews of process performances, product quality and of the quality management systems and advocating continual improvement.

• To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.
• To conduct training program and ensure it effectiveness.
• To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment.
• To follow safety & use of required personal protective equipment during day to day activities.
• To ensure maintenance of housekeeping at shop floor and reporting day to day activities to QC head and in absence delegate change to second line manager.
• To participate in laboratory internal audits, customer audits, health authority inspection.
• Awareness of IMS systems (ISO14001:2015 and ISO45001:2018)

Travel Estimate

Low

Job Requirements

Educational Qualification

M.Sc Chemistry

Experience

15+ years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).