Job Summary
Assume critical role in performing and managing the Production Operations in manufacturing facility. Must manage and document, manufacturing / packaging operations as per cGMP / SOP and BMR requirements.
Manages Team Leads and Operators on a daily basis. Conduct periodic checks on documents and take corrective actions to prevent deviations.
Ensure target production numbers are met on a daily basis and cGMP documents are completed in a timely manner. Plays an active role for adherence to GMP and safety.
Area Of Responsibility
- Based on the production planning, coordinates and supervises the daily / weekly manufacturing activities of production staff in assigned areas.
- Coordinates work activities with other supervisors and sets priorities for the team to ensure task completion.
- Prepares and trains employees on manufacturing related SOPs.
- Ensures processes and procedures are followed as per batch records, SOPs, and protocols and the quality specification are met.
- Oversees scale-up, Exhibit, Characterization and validation batch execution as well as the execution of cleaning verification / validation protocols.
- Initiates any event / investigations and change controls.
- Applies expertise to solve standard and non-standard problems within the manufacturing area.
- Works within budgetary / financial objectives, applying knowledge of profit drivers to work processes.
- Resolves day-to-day or routine manufacturing problems using defined processes.
- Works / brainstorms with work team and provides suggestions for solutions that contain the appropriate level of risk; ensures work team understands and supports the focus on operational excellence.
- Effectively builds alignment on difficult issues.
- Follows the DEA Controlled Substance SOPs and reports any violation to Manager.
Work Conditions :
Manufacturing / Production / Laboratory environment
Environmental related to manufacturing / production / Laboratory environments :
- Noise : Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
- Fumes : Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
- Odors : Unpleasant smells.
- Gases : Examples include carbon monoxide and helium.
- Dust : Airborne particles of any kind, such as textile dust, wood, and silica.
- Hazards : Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts;
working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.
Physical Requirements :
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear.
The employee is frequently required to stand, walk, sit and stoop, kneel, crouch, crawl, push, and bend.
- Must be capable of bending and lifting, moving and / or carrying up to approximately 50 - 75 pounds.
- Must have the ability to navigate office, lab, warehouse and / or plant floor working environments, stand, ambulates, and reaches.
- Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses / goggles, and safety shoes.
Travel Estimate
Up to 0 %
Education and Job Qualification
- Minimum of High School / Trade School / Vocational School Diploma, GED, or equivalent; B.S. in related field preferred.
- Extensive knowledge of granulation, blending / mixing, compression (AWC machines), coating, encapsulation equipment
- Able to work extended hour to achieve manufacturing schedule when required.
- Builds confidence and respect of others through a positive and energizing style
- Demonstrated proficiency with MS Office applications.
- Ability to work under pressure and meet tight deadlines.
- Good problem solving and decision making skills.
- Sound knowledge of cGMP's, SOP's, FDA guidelines and safety regulations
- Demonstrated excellent communication : verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude. .
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
Experience
- Minimum of four years of pharmaceutical manufacturing experience required.
- 2 -3+ years of experience, and a Master's Degree in Science or Engineering considered.
Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.
In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage;
life insurance; disability insurance; (k) savings plan; flexible spending accounts; and the employee assistance program.
Employees also receive various paid time off benefits, including vacation time and sick time.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.
If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department / team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees 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 the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives :
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and / or search firms for this job posting.
Resumes submitted to any Taro employee by a third party agency and / or search firm without a valid written & signed search agreement, will become the sole property of Taro.
No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.