Halol Manufacturing In charge (Aerosol & Nasal Spray)

Title:

Manufacturing In-charge (Aerosol & Nasal Spray)

Business Unit:

SGO

Job Grade

Manager

Location:

Halol-II

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 DESCRIPTION-

1.           Preparation and signing authority for:

• Commercial product / stability batches / exhibit batches / characterization batches– Master Batch Manufacturing Record.

• Risk Assessment, process Validation protocol, incident and investigation report, action, compliance, and closure.

• CAPA plans and closure.

• Protocols & reports.

• Internal Quality Audit/ Regulatory Quality Audit Compliance and closure.

• Change control, Standard Operating Procedure, Planned Modification.

2.           Responsible for training activity of staff members, technicians and contract workers of Aerosol and nasal spray department as a Department training coordinator (DTC). As a part of DTC, below activities shall be performed as -

• Preparation and updating of Master Training Needs Matrix of their respective department for different job role(s) in consultation with LTC and Department Head and shall submit the same to L&OD department.

• Assign training activities in LMS for existing employees on need basis as per the Job Roles mentioned in MTNM. In case of any learning activities i.e. SOP/modules etc.is uploaded in LMS, deadline/Due date to be mentioned.

• Assign training activities to Job roles for Contract workers.

• Scheduling and coordinating or conducting training, as applicable.

• Preparation and updating of Trainer Qualification Log of their respective department and shall submit the same to L&OD department.

• Track pending trainings in LMS (applicable only for employees) and ensure training completion for their respective department personnel in acknowledgement with Department Head.

• Maintain and submission of the manual training records to L&OD department after the execution of training and upload in LMS, wherever applicable.

• Submission of executed Master Data Change form of the employees (for addition as well as removal of job roles) to L&OD department at the time of joining as well as relieving from the job. In case of relieving of employees training transcript shall be submitted to L&OD department.

• Review certification of training completion of new employee(s) /any personnel after the completion of assigned trainings and existing employee(s) as per need basis.

• Approved questionnaire/evaluation form and model answer sheet for training assessment questionnaire shall be submitted to L&OD department once SOP get approved /or/ it is uploaded in LMS for training purpose.

• DTC from the respective departments shall waive off the training in LMS only if there is a proper justification and after approval from the Site Quality Head/QA Head / Designee in the justification form.

• If any issue found related to LMS activity, then shall be inform to Department Head.

3.           To assist the DGM for planning and execution of batch manufacturing and controlling the functions related of Aerosol department - Manufacturing (DPI, MDI and Nasal Spray). Responsible for overall production activities of the manufacturing area on daily basis in achieving total production requirements in quantity, quality with cGMP requirement.

4.           Work allocation to the operators and production supervisor as per production planning.

5.           Optimization of the resources like men, materials and machines in manufacturing area.

6.           Training the men-power to meet the organizational goals and achieve GMP compliance.

7.           To co-ordinate with quality assurance (QA) department for release of batch, cleaning & process validation.

8.           To co-ordinate with engineering department for machine maintenance and preventive maintenance schedule.

9.           To co-ordinate with warehouse department for issuance of materials to achieve schedule plan. Designation and monitoring of storage conditions for materials and products.

10.         Monitoring & control of manufacturing environmental and plant hygiene.

11.         To co-ordinate with FDD / PDD (R & D) for execution of characterization/trial/exhibit batches.

12.         Preparation and review of risk assessment, process validation protocol whenever is required.

13.         Review, updation & execution of MBMR / MBPR/ SOP /Qualification Protocol whenever is required.

14.         Review of Master Formula & Master Product Specification which is received from FDD whenever is required.

15.         Responsible for raising the purchase requirement for procurement of change parts of machine and miscellaneous items as when required.

16.         To co-ordinate with purchase department for status of purchase order and delivery of consignment from supplier as when required.

17.         To prepare the daily report, monthly report and quarterly report of department on regular basis.

18.         Shall be participating in Internal Quality Audit. 

19.         Responsible for ensuring market complaints, failures deviations are investigated and corrective and preventive actions are implemented as per set timeline.

20.         To adhere with EHS requirements and compliance the observation related to EHS.

Travel Estimate

Low

Job Requirements

Educational Qualification

B. Pharm or M. Pharm

Experience

12 to 14 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).