Quality Control Supervisor

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Role Description:

• A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.
• Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.
• All incumbents are responsible for following applicable Division & Company policies and procedures.
• Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.
• Supervisory responsibilities within a single site.

Responsibilities:

• QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.
• Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.
• Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.
• Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.
• Develop systems and processes for proactive management of laboratory logistics and instrumentation.
• Oversee ordering of lab supplies in observance of Departmental Budget constraints.
• Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.
• Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.
• SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.
• Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.
• Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.
• Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.
• Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total 100% Qualifications 

Requirements:

Education & Experience

• Minimal acceptable level of education, work experience and certifications required for the job
• BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.
• 3+ years’ QC lab supervisory experience in pharmaceutical industry.
• Demonstrated management and leadership experience with strong interpersonal and influencing skills.

Knowledge 

• Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
• Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.
• Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.
• Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.

Skills & Abilities

• Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
• Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.
• Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
• Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.
• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
• Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.
• Excellent written and oral communications skills with a strong emphasis on organizational capabilities.

Physical Requirements

• Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
• Employee is frequently required to use hands to handle or feel.
• The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.
• The noise level in the work environment is usually moderate.
• The work environment is representative of a group laboratory environment.
• QC Lab Management, Workload Management, SOPs, Staff Development